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.btn-secondary{background:rgba(255,255,255,.14);color:#fff;border-color:rgba(255,255,255,.25)}\n@media (max-width:1080px){.guidaio-v3 .hero-grid,.guidaio-v3 .trust-grid,.guidaio-v3 .company-grid,.guidaio-v3 .setup-grid,.guidaio-v3 .availability{grid-template-columns:1fr}.guidaio-v3 .grid-3,.guidaio-v3 .res-grid,.guidaio-v3 .plan-grid{grid-template-columns:repeat(2,minmax(0,1fr))}}\n@media (max-width:700px){.guidaio-v3{padding:12px 8px 48px}.guidaio-v3 .hero{padding:20px}.guidaio-v3 section.block{padding:20px}.guidaio-v3 .grid-2,.guidaio-v3 .grid-3,.guidaio-v3 .res-grid,.guidaio-v3 .plan-grid,.guidaio-v3 .bestnot,.guidaio-v3 .availability{grid-template-columns:1fr}.guidaio-v3 h1.title{font-size:28px}}\n\u003c\/style\u003e\n\u003cdiv class=\"guidaio-v3\" itemscope itemtype=\"https:\/\/schema.org\/SoftwareApplication\"\u003e\n\u003cmeta itemprop=\"name\" content=\"Cruxi: AI Platform for FDA 510(k) Regulatory Submissions\"\u003e\n\u003cmeta itemprop=\"description\" content=\"Cruxi uses specialised AI agents for FDA 510(k) classification, predicate analysis and eSTAR drafting. Free assessment, no card. Credits from USD 100.\"\u003e\n\u003cdiv class=\"hero\"\u003e\u003cdiv class=\"hero-grid\"\u003e\n\u003cdiv\u003e\n\u003cdiv class=\"hero-head\"\u003e\n\u003cdiv class=\"logo-tile\"\u003e\u003cimg src=\"https:\/\/cruxi.ai\/assets\/logo.png\" alt=\"Cruxi logo\" itemprop=\"image\" loading=\"lazy\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"name-block\"\u003e\n\u003cspan class=\"eyebrow\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"m12 3-1.9 5.8a2 2 0 0 1-1.3 1.3L3 12l5.8 1.9a2 2 0 0 1 1.3 1.3L12 21l1.9-5.8a2 2 0 0 1 1.3-1.3L21 12l-5.8-1.9a2 2 0 0 1-1.3-1.3Z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Gov Legal · Workflow Automation\u003c\/span\u003e\u003ch1 class=\"title\" itemprop=\"name\"\u003eCruxi\u003c\/h1\u003e\n\u003cp class=\"lede justify\" itemprop=\"description\"\u003eCruxi is a regulatory submission platform for medical device teams. Specialized AI agents handle device classification, predicate analysis, eSTAR drafting and RTA checks, while a marketplace of 25+ directories connects companies with vetted regulatory consultants and providers.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"badge-row\"\u003e\n\u003cspan class=\"badge ok\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cpath d=\"m9 12 2 2 4-4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Active\u003c\/span\u003e\u003cspan class=\"badge ok\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"\u003e\u003c\/path\u003e\u003cpath d=\"m9 12 2 2 4-4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e GDPR compliant\u003c\/span\u003e\u003cspan class=\"badge brand\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 12 20 22 4 22 4 12\"\u003e\u003c\/polyline\u003e\u003crect x=\"2\" y=\"7\" width=\"20\" height=\"5\"\u003e\u003c\/rect\u003e\u003cline x1=\"12\" y1=\"22\" x2=\"12\" y2=\"7\"\u003e\u003c\/line\u003e\u003cpath d=\"M12 7H7.5a2.5 2.5 0 0 1 0-5C11 2 12 7 12 7z\"\u003e\u003c\/path\u003e\u003cpath d=\"M12 7h4.5a2.5 2.5 0 0 0 0-5C13 2 12 7 12 7z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Free plan\u003c\/span\u003e\u003cspan class=\"badge\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"22 7 13.5 15.5 8.5 10.5 2 17\"\u003e\u003c\/polyline\u003e\u003cpolyline points=\"16 7 22 7 22 13\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e Freemium\u003c\/span\u003e\u003cspan class=\"badge\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e No public API\u003c\/span\u003e\u003cspan class=\"badge brand\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cpath d=\"m9 12 2 2 4-4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Verified by Guidaio\u003c\/span\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"tbd-row\"\u003e\n\u003cdiv\u003e\n\u003cdiv class=\"label\"\u003eCategories\u003c\/div\u003e\n\u003cdiv class=\"chip-row\"\u003e\n\u003ca class=\"chip cat\" href=\"\/collections\/gov-legal\"\u003eGov Legal\u003c\/a\u003e\u003ca class=\"chip cat\" href=\"\/collections\/workflow-automation\"\u003eWorkflow Automation\u003c\/a\u003e\u003ca class=\"chip cat\" href=\"\/collections\/document-processing-files\"\u003eDocument Processing Files\u003c\/a\u003e\u003ca class=\"chip cat\" href=\"\/collections\/report-generation\"\u003eReport Generation\u003c\/a\u003e\u003ca class=\"chip cat\" href=\"\/collections\/technical-writing\"\u003eTechnical Writing\u003c\/a\u003e\u003ca class=\"chip cat\" href=\"\/collections\/rag-semantic-search\"\u003eRag Semantic Search\u003c\/a\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv\u003e\n\u003cdiv class=\"label\"\u003eTarget domains\u003c\/div\u003e\n\u003cdiv class=\"chip-row\"\u003e\n\u003ca class=\"chip dom\" href=\"\/collections\/quality-regulatory\"\u003eQuality Regulatory\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/healthcare-medicine\"\u003eHealthcare Medicine\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/biotech-pharma\"\u003eBiotech Pharma\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/mechanical-manufacturing\"\u003eMechanical Manufacturing\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/science-r-d\"\u003eScience R D\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/legal-justice\"\u003eLegal Justice\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/procurement\"\u003eProcurement\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/cybersecurity\"\u003eCybersecurity\u003c\/a\u003e\u003ca class=\"chip dom\" href=\"\/collections\/freelancers-entrepreneurs\"\u003eFreelancers Entrepreneurs\u003c\/a\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"cta-row\"\u003e\n\u003ca class=\"btn btn-primary\" href=\"https:\/\/cruxi.ai\/\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"16\" height=\"16\"\u003e\u003cpath d=\"M15 3h6v6\"\u003e\u003c\/path\u003e\u003cpath d=\"M10 14 21 3\"\u003e\u003c\/path\u003e\u003cpath d=\"M18 13v6a2 2 0 0 1-2 2H5a2 2 0 0 1-2-2V8a2 2 0 0 1 2-2h6\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Discover Cruxi\u003c\/a\u003e\u003ca class=\"btn btn-secondary\" href=\"https:\/\/cruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/demo-project.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolygon points=\"6 3 20 12 6 21 6 3\"\u003e\u003c\/polygon\u003e\u003c\/svg\u003e Run a free assessment\u003c\/a\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003caside class=\"snapshot\"\u003e\u003ch3\u003eSnapshot\u003c\/h3\u003e\n\u003cdl\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003ePricing model\u003c\/dt\u003e\n\u003cdd\u003eFreemium\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eStarts at\u003c\/dt\u003e\n\u003cdd\u003e\n\u003cspan class=\"price-big\"\u003eUSD100.00\u003c\/span\u003e\u003csmall\u003eUSD · per credits\u003c\/small\u003e\n\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eFree plan\u003c\/dt\u003e\n\u003cdd\u003eYes\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eAPI available\u003c\/dt\u003e\n\u003cdd\u003eNo\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eDeployment\u003c\/dt\u003e\n\u003cdd\u003eWeb app\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eLanguages\u003c\/dt\u003e\n\u003cdd\u003eEnglish\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eTool status\u003c\/dt\u003e\n\u003cdd\u003eActive\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdt\u003eCountry of origin\u003c\/dt\u003e\n\u003cdd\u003e🇫🇷 France\u003c\/dd\u003e\n\u003c\/div\u003e\n\u003c\/dl\u003e\u003c\/aside\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003cnav class=\"toc\" aria-label=\"Page sections\"\u003e\u003ca href=\"#what\"\u003eWhat is it\u003c\/a\u003e\u003ca href=\"#bestnot\"\u003eWhen to use Cruxi \/ When not to\u003c\/a\u003e\u003ca href=\"#how\"\u003eHow to use\u003c\/a\u003e\u003ca href=\"#proscons\"\u003ePros \u0026amp; Cons\u003c\/a\u003e\u003ca href=\"#pricing\"\u003ePricing\u003c\/a\u003e\u003ca href=\"#trust\"\u003eTrust \u0026amp; Privacy\u003c\/a\u003e\u003ca href=\"#watch\"\u003eWatch-outs\u003c\/a\u003e\u003ca href=\"#setup\"\u003eSetup \u0026amp; Integrations\u003c\/a\u003e\u003ca href=\"#company\"\u003eCompany\u003c\/a\u003e\u003ca href=\"#resources\"\u003eResources\u003c\/a\u003e\u003ca href=\"#faq\"\u003eFAQ\u003c\/a\u003e\u003ca href=\"#conclusion\"\u003eConclusion\u003c\/a\u003e\u003c\/nav\u003e\n\u003csection class=\"block\" id=\"what\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eOverview\u003c\/span\u003e\u003ch2\u003eWhat is Cruxi?\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"grid-2\"\u003e\n\u003cdiv class=\"rich justify\"\u003e\n\u003cp\u003eCruxi is a regulatory submission platform for medical device companies, operated by Tipmunk SASU. Its centre of gravity is the \u003cb\u003eFDA 510(k)\u003c\/b\u003e. The product carries a device from first intake through classification, predicate selection, regulatory assessment, evidence planning, eSTAR drafting and final packaging, and claims to produce a complete draft in four to five hours where traditional preparation runs six to twelve months.\u003c\/p\u003e\n\u003cp\u003eThe work is done by named, purpose-built agents rather than a general chatbot. \u003ci\u003eNucAgent\u003c\/i\u003e reads the device description and intended use to pin down product code, regulation number and device class with confidence scores. \u003ci\u003ePreAgent\u003c\/i\u003e scores candidate predicates on intended use, technological characteristics, performance data and regulatory history, weighing recalls and MAUDE adverse event records so that a predicate with a poor post-market record is not picked by accident. A reasoning agent then works through all 18 eSTAR sections and drafts content. All three run against an FDA database Cruxi maintains itself, covering product codes, the text of 21 CFR, cleared 510(k) devices, guidance documents, recognised IEC and ISO standards, recalls and safety data. That is how the platform justifies its \u003cb\u003ezero hallucinations\u003c\/b\u003e claim: statements are anchored either in that database or in the user's own uploaded files, with citations you can follow.\u003c\/p\u003e\n\u003cp\u003eThe design is deliberately human-in-the-loop. Cruxi never files anything with the FDA, never presses submit in eSTAR and never takes a regulatory decision. Every classification, predicate and drafted section is a recommendation the user accepts, modifies or rejects, and an optional second step routes the finished draft to a vetted FDA consultant for review.\u003c\/p\u003e\n\u003cp\u003eA second business sits alongside the software: a marketplace of more than 25 regulatory directories covering FDA US Agents, EU Authorised Representatives, GDPR Article 27 representatives, eIFU platforms, GUDID tools, testing laboratories and cosmetics compliance, with a request-for-quote system. Fourteen submission types are advertised, but only the 510(k) is fully open: De Novo, PMA, IDE, Q-Submission, Breakthrough, EU MDR, UKCA, Health Canada and TGA are described as \u003ci\u003ein beta and calibration\u003c\/i\u003e, with access limited to selected groups.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv\u003e\n\u003ch3 style=\"font-size:14px;margin-bottom:12px;color:var(--gv3-brand-ink);text-transform:uppercase;letter-spacing:.08em\"\u003eWhat it does\u003c\/h3\u003e\n\u003cul class=\"brand-list\"\u003e\n\u003cli\u003eClassify a medical device and return its product code, regulation number, device class and regulatory pathway\u003c\/li\u003e\n\u003cli\u003eIdentify and score predicate devices to support a substantial equivalence argument\u003c\/li\u003e\n\u003cli\u003eProduce a regulatory assessment across all 18 eSTAR sections\u003c\/li\u003e\n\u003cli\u003eDraft submission sections with every claim traced back to its source\u003c\/li\u003e\n\u003cli\u003eRun automated Refuse to Accept (RTA) readiness checks before filing\u003c\/li\u003e\n\u003cli\u003eMap required evidence and generate a device-specific testing matrix\u003c\/li\u003e\n\u003cli\u003eGenerate and export a complete, correctly formatted 510(k) submission package\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block soft\" id=\"bestnot\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eAudience\u003c\/span\u003e\u003ch2\u003eWhen to use Cruxi \/ When not to\u003c\/h2\u003e\n\u003cp class=\"lead\"\u003eA quick filter to help you decide if Cruxi is the right fit.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"bestnot\"\u003e\n\u003cdiv class=\"card for\"\u003e\n\u003ch3\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"16\" height=\"16\"\u003e\u003cpath d=\"M7 10v12\"\u003e\u003c\/path\u003e\u003cpath d=\"M15 5.88 14 10h5.83a2 2 0 0 1 1.92 2.56l-2.33 8A2 2 0 0 1 17.5 22H4a2 2 0 0 1-2-2v-8a2 2 0 0 1 2-2h2.76a2 2 0 0 0 1.79-1.11L12 2a3.13 3.13 0 0 1 3 3.88Z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e When to use Cruxi\u003c\/h3\u003e\n\u003cul class=\"brand-list\"\u003e\n\u003cli\u003eRegulatory affairs teams at medical device manufacturers preparing an FDA 510(k) or eSTAR submission\u003c\/li\u003e\n\u003cli\u003eIndependent regulatory consultants and agencies running several client submissions a month\u003c\/li\u003e\n\u003cli\u003eMedtech startups that need submission-grade regulatory work without a full in-house RA department\u003c\/li\u003e\n\u003cli\u003eQuality and QA\/RA managers building evidence plans, testing matrices and RTA-proof documentation\u003c\/li\u003e\n\u003cli\u003eProcurement and project leads sourcing FDA US Agents, EU Authorised Representatives or testing laboratories through the directories\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"card not\"\u003e\n\u003ch3\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"16\" height=\"16\"\u003e\u003cpath d=\"M17 14V2\"\u003e\u003c\/path\u003e\u003cpath d=\"M9 18.12 10 14H4.17a2 2 0 0 1-1.92-2.56l2.33-8A2 2 0 0 1 6.5 2H20a2 2 0 0 1 2 2v8a2 2 0 0 1-2 2h-2.76a2 2 0 0 0-1.79 1.11L12 22a3.13 3.13 0 0 1-3-3.88Z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e When not to use Cruxi\u003c\/h3\u003e\n\u003cul class=\"brand-list\"\u003e\n\u003cli\u003eAnyone expecting the tool to file with the FDA or make the regulatory call: it never submits and never decides\u003c\/li\u003e\n\u003cli\u003eTeams looking for formal legal, medical or regulatory advice, which the terms of service explicitly exclude\u003c\/li\u003e\n\u003cli\u003eDevelopers wanting programmatic access, since there is no public API, no SDK and no mobile application\u003c\/li\u003e\n\u003cli\u003eIndividuals, students and hobbyists, as pricing starts at USD 100 per credit and targets funded device programmes\u003c\/li\u003e\n\u003cli\u003eCompanies whose priority pathway is De Novo, PMA, EU MDR, UKCA, Health Canada or TGA, all still in beta with restricted access\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block soft\" id=\"how\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eGet started\u003c\/span\u003e\u003ch2\u003eHow to use Cruxi\u003c\/h2\u003e\n\u003cp class=\"lead\"\u003eA typical end-to-end flow, from setup to results.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003col class=\"steps\"\u003e\n\u003cli\u003eStart with the free regulatory assessment: no account, no card, roughly a minute for a first read on classification, pathway and timeline\u003c\/li\u003e\n\u003cli\u003eOpen the read-only demo project to walk through a real 510(k) end to end before committing anything\u003c\/li\u003e\n\u003cli\u003eCreate an account and sign in with a Google account, or with an email and a twelve-character password\u003c\/li\u003e\n\u003cli\u003eEnter your administrative contacts and device intake details: description, intended use and technology\u003c\/li\u003e\n\u003cli\u003eLet the classification agent return the product code, regulation number and device class with its confidence scoring\u003c\/li\u003e\n\u003cli\u003eReview the scored predicate shortlist and choose the device you will argue substantial equivalence against\u003c\/li\u003e\n\u003cli\u003eWork through the regulatory assessment covering all 18 eSTAR sections and the evidence map it produces\u003c\/li\u003e\n\u003cli\u003eUpload and organise your supporting documents against the generated evidence and testing plan\u003c\/li\u003e\n\u003cli\u003eDraft and revise sections in the eSTAR editor, then run the RTA check and the final QA review\u003c\/li\u003e\n\u003cli\u003eExport the complete submission package, and optionally send the draft to a vetted FDA consultant for review\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/section\u003e\n\u003csection class=\"block\" id=\"proscons\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eQuick read\u003c\/span\u003e\u003ch2\u003ePros \u0026amp; Cons\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"grid-2\"\u003e\n\u003cdiv class=\"pc pros\"\u003e\n\u003ch3\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cpath d=\"m9 12 2 2 4-4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Pros\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eGenuinely specialised: a complete 510(k) pathway, not a general assistant pointed at regulatory work\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eAnswers are anchored in an FDA database Cruxi maintains itself, covering product codes, 21 CFR, cleared devices, guidance, standards, recalls and MAUDE data, rather than model recall\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eSource traceability is a stated design principle, with claims linked back to regulations, public 510(k) summaries or the user's own documents\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eA real free entry point: the quick regulatory assessment needs no account and no card, and project creation is free\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ePrices are published openly, purchased credits never expire, and credits are only deducted once a service completes successfully\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eThe trust documentation is unusually candid for a company this size and states plainly what is \u003ci\u003enot\u003c\/i\u003e done, including the absence of application-layer database encryption and of any zero-retention AI claim\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eHuman expert review is available on demand through a vetted consultant network without ever being forced on the user\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"pc cons\"\u003e\n\u003ch3\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"16\" height=\"16\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cline x1=\"4.93\" y1=\"4.93\" x2=\"19.07\" y2=\"19.07\"\u003e\u003c\/line\u003e\u003c\/svg\u003e Cons\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eAn unresolved contradiction about where the company actually is: the terms, the privacy policy and the contact page all name a French company registered in Paris, while the Compliance \u0026amp;amp; Contacts page states that Cruxi is headquartered in the United States and not established in the EU\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eThe stated legal entity and its Paris trade register number could not be found in the French public registries consulted\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eSOC 2 Type II and HIPAA are claimed once, on the homepage, and appear nowhere in the trust centre that describes itself as verified-only\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eNine of the fourteen advertised services are in beta with restricted access, so the headline offer is broader than what is actually open\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eNo public API, no mobile application and no third-party product integrations\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eNo hosting country or region is published, database records are explicitly not encrypted at application layer, and confidential device documents pass through third-party AI subprocessors\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\u003e\u003c\/line\u003e\u003cline x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\u003e\u003c\/line\u003e\u003c\/svg\u003e \u003cspan\u003eThe company and the domain are very recent, with the domain registered in August 2025 and first archived in December 2025, for work of this consequence\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block soft\" id=\"pricing\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003ePricing\u003c\/span\u003e\u003ch2\u003ePricing \u0026amp; Plans\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cp class=\"rich justify\" style=\"color:var(--gv3-ink-2);margin:0 0 18px;max-width:80ch\"\u003eA free entry point exists and requires no payment details: the quick regulatory assessment runs without an account, and creating a project after signing in is free. Beyond that, Cruxi is credit-based. The published unit rate is USD 100 per credit, purchasable in any quantity, which makes USD 100 the lowest paid entry point. The cheapest complete service is a single microservice at USD 200, or two credits, while the full 510(k) workflow costs USD 1,000, or ten credits. All prices are quoted in US dollars.\u003c\/p\u003e\n\u003cdiv class=\"plan-grid\"\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eFree\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003equick regulatory assessment with no account and no card\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eplus free project creation after signing in\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan featured\"\u003e\n\u003cspan class=\"pill\"\u003eMost popular\u003c\/span\u003e\u003cdiv class=\"pname\"\u003eSingle microservice\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eUSD 200\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eor 2 credits\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003efor classification\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003epredicate search\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eregulatory assessment or an RTA check\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eFull 510(k) workflow\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eUSD 1\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e000\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eor 10 credits\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ecovering classification\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003epredicate analysis\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eregulatory assessment\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eevidence and testing plan and eSTAR-style draft content\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003e510(k) Regulatory Pathway Assessment and Roadmap\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eUSD 300\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003edelivered in one day\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eStarter credit pack\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e5 credits for USD 500\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eat USD 100 per credit\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eProfessional credit pack\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e15 credits for USD 1\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e350\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eat USD 90 per credit\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ea 10% discount\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eAgency credit pack\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e40 credits for USD 3\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003e200\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eat USD 80 per credit\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ea 20% discount\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eCustom credit pack\u003c\/div\u003e\n\u003cul\u003e\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eany quantity at USD 100 per credit\u003c\/span\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003eProfessional Membership\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eUSD 500 per month for 50 monthly credits\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003epriority support\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ea dedicated account manager\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003eadvanced analytics and unlimited microservice access\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"plan\"\u003e\n\u003cdiv class=\"pname\"\u003ePlan 10\u003c\/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003ePurchased credits never expire\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e \u003cspan\u003emembership credits expire at the end of each billing cycle and are consumed before purchased credits\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"pricing-extras\"\u003e\n\u003cdiv class=\"offer\"\u003e\n\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M2 9a3 3 0 1 1 0 6v2a2 2 0 0 0 2 2h16a2 2 0 0 0 2-2v-2a3 3 0 1 1 0-6V7a2 2 0 0 0-2-2H4a2 2 0 0 0-2 2Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m9 14 6-6\"\u003e\u003c\/path\u003e\u003ccircle cx=\"9.5\" cy=\"9.5\" r=\".5\"\u003e\u003c\/circle\u003e\u003ccircle cx=\"14.5\" cy=\"14.5\" r=\".5\"\u003e\u003c\/circle\u003e\u003c\/svg\u003e\u003cdiv\u003e\n\u003cb\u003eSpecial offers\u003c\/b\u003e — Volume discounts on credit packs: Professional at 15 credits for USD 1,350 (10% off) and Agency at 40 credits for USD 3,200 (20% off) · Purchased credits carry no expiry date, and credits are not deducted when a service fails · A launch promotion advertising 90% off for three months, at USD 100 for the full workflow and USD 20 per single service, was valid through 21 May 2026 and is therefore expired, although it was still displayed on the homepage and the product page in August 2026 · No student, jobseeker, non-profit or startup pricing is published\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"affiliate-note\"\u003ePrices and plans listed above may evolve. Always check the official pricing page before subscribing.\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block\" id=\"trust\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eTrust \u0026amp; Privacy\u003c\/span\u003e\u003ch2\u003eData, GDPR \u0026amp; hosting\u003c\/h2\u003e\n\u003cp class=\"lead\"\u003eA consolidated view of how Cruxi handles your data.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"trust-grid\"\u003e\n\u003cdiv class=\"col\"\u003e\n\u003cdiv class=\"trust-card\"\u003e\n\u003ch3\u003eGDPR overview\u003c\/h3\u003e\n\u003cp class=\"justify\" style=\"color:var(--gv3-ink-2);margin:0\"\u003eCruxi publishes a complete documentary set: a privacy policy effective 20 April 2026, a data processing agreement, a named subprocessor list, a cookie policy and a data subject request page. The in-product controls are concrete, with JSON export of profile, project, workflow, message and consent records, self-service project and account deletion, and separately tracked access, portability, rectification and erasure requests. Cookie consent is collected before any non-essential tag loads for EU and UK visitors, and Tipmunk SASU is named as controller. The homepage claims GDPR compliance outright. One page contradicts all of this: \u003cb\u003eCompliance \u0026amp;amp; Contacts\u003c\/b\u003e states that Cruxi is not established in the European Union, does not direct services to EU or UK individuals, sits outside GDPR Article 3(2), and has therefore appointed no Article 27 representative. No standard contractual clauses or transfer mechanism are mentioned anywhere.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"trust-card\"\u003e\n\u003ch3\u003eWho owns the data?\u003c\/h3\u003e\n\u003cp class=\"justify\" style=\"color:var(--gv3-ink-2);margin:0 0 12px\"\u003eUnder the terms of service, users keep their rights in everything they upload or create on the platform. Cruxi processes that content only to deliver the service, operate its infrastructure, support the account and meet contractual or legal obligations. The data processing agreement sets the roles out plainly: the customer is the controller, Cruxi the processor, and Tipmunk SASU is named as controller for platform operations unless a separate written agreement says otherwise. Private project data is not shared with other customers, consultants or partners unless the user explicitly authorises it, and Cruxi states that it does not sell customer data. Responsibility for uploaded content and for the use made of generated outputs stays with the user.\u003c\/p\u003e\n\u003ch3\u003eReuse rights\u003c\/h3\u003e\n\u003cp class=\"justify\" style=\"color:var(--gv3-ink-2);margin:0\"\u003eUsers may reuse what the platform produces without asking permission. Classifications, predicate analyses, regulatory assessments, drafted eSTAR sections and the exported package are theirs to edit, hand to a consultant or file with the FDA, and the terms are explicit that reviewing those outputs and deciding how to use them is the user's own responsibility. On Cruxi's side, the declared purposes are running the platform, processing the AI tasks the user requests, billing, fraud prevention, security, troubleshooting and answering support or privacy requests. AI processing is subcontracted to Google Vertex AI \/ Gemini and to OpenAI. The product FAQ states that device information, documents and submission drafts are not used to train public models, although the trust page stops short of claiming zero-retention AI processing.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"trust-card\"\u003e\n\u003ch3\u003eData retention \u0026amp; training\u003c\/h3\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eRetention summary\u003c\/div\u003e\n\u003cdiv class=\"v justify\"\u003eCruxi publishes no fixed retention period. Workspace, consent and privacy-request records are kept only as long as needed to run the service, fulfil requests, meet security and operational needs and satisfy legal obligations. A monthly scheduled job purges stale inactive projects and accounts, with retention warnings possible before it runs; active subscriptions and memberships are excluded from automatic purge. Users can delete individual projects from the interface, which also cleans up linked workflow artefacts, and delete their account from the in-app Data and Privacy menu. Formal access, portability, rectification and erasure requests are tracked separately from immediate self-service deletion. Cruxi relies on managed-provider backups and promises no self-service restoration after a hard delete. On termination, customer data is deleted or returned according to configuration, customer instructions and legal obligations.\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eTrains on customer data\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003cspan class=\"badge ok\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e No\u003c\/span\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eSubprocessors disclosed\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003cspan class=\"badge ok\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolyline points=\"20 6 9 17 4 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e Yes\u003c\/span\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eDPA available\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003cspan class=\"badge ok\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M14 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V8z\"\u003e\u003c\/path\u003e\u003cpolyline points=\"14 2 14 8 20 8\"\u003e\u003c\/polyline\u003e\u003cpath d=\"m9 15 2 2 4-4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Yes\u003c\/span\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eGDPR contact\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003ca href=\"mailto:privacy@cruxi.ai\"\u003eprivacy@cruxi.ai\u003c\/a\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"col\"\u003e\u003cdiv class=\"trust-card\"\u003e\n\u003ch3\u003eHosting summary\u003c\/h3\u003e\n\u003cp class=\"justify\" style=\"color:var(--gv3-ink-2);margin:0 0 14px\"\u003eCruxi names its infrastructure openly but not its geography. Application hosting, file storage, networking and logging run on Google Cloud Platform; the managed operational database is MongoDB Atlas; AI processing goes to Google Vertex AI \/ Gemini and to OpenAI; payments run through Stripe; sign-in uses Google identity services. Traffic is served over HTTPS\/TLS at the hosting edge and at application entry points. The primary production Google Cloud Storage bucket holding uploaded 510(k) documents and generated submission artefacts is encrypted at rest by default with a customer-managed Cloud KMS key. Cruxi states explicitly that MongoDB records and other application-layer fields are not field-encrypted by its own code and relies on provider-managed encryption there. No hosting country and no region are published anywhere on the site. The site's resolved IP address is a Google anycast node located in the United States, which describes the front end rather than where customer data actually resides.\u003c\/p\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block watch\" id=\"watch\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eWatch-outs\u003c\/span\u003e\u003ch2\u003eThings to keep in mind\u003c\/h2\u003e\n\u003cp class=\"lead\"\u003eRisks and trade-offs to weigh before adopting Cruxi.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cul class=\"brand-list\" style=\"grid-template-columns:repeat(2,1fr);display:grid;gap:12px 24px\"\u003e\n\u003cli\u003eUnclear jurisdiction: the terms, privacy policy and contact page name a French company in Paris while the Compliance and Contacts page declares Cruxi established in the United States and outside the EU, so a user cannot tell which law governs the contract or where a dispute would be heard\u003c\/li\u003e\n\u003cli\u003eThe stated legal entity and its Paris trade register number were not found in the French public registries consulted, which is a basic diligence gap before entrusting a multi-million-euro device programme\u003c\/li\u003e\n\u003cli\u003eSOC 2 Type II and HIPAA compliance are asserted on the homepage but absent from the trust centre that presents itself as verified-only and from the data processing agreement, so they should be treated as claims rather than facts\u003c\/li\u003e\n\u003cli\u003eA polished AI draft can read as complete while a requirement is missing; the promise of a four-to-five hour submission invites teams to skip the human review the vendor itself insists on, and liability for the filing remains entirely human\u003c\/li\u003e\n\u003cli\u003eConfidential device documents and drafts transit third-party AI subprocessors, no hosting country or region is published, database records are not encrypted at application layer, and permanent deletion cannot be undone by the user\u003c\/li\u003e\n\u003cli\u003eCommercial signals need checking at source: a launch promotion advertising 90% off ran out on 21 May 2026 yet was still displayed in August, and the 4.8 out of 5 rating over 150 reviews is authored by Cruxi itself in the site's structured data\u003c\/li\u003e\n\u003cli\u003eNine of the fourteen advertised submission types are in beta with restricted access, and the company and domain date only from 2025, so capability and continuity both deserve verification before a programme depends on them\u003c\/li\u003e\n\u003c\/ul\u003e\u003c\/section\u003e\n\u003csection class=\"block\" id=\"setup\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eSetup\u003c\/span\u003e\u003ch2\u003eSetup \u0026amp; Integrations\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"setup-grid\"\u003e\n\u003cdiv class=\"setup-card\"\u003e\n\u003ch3 style=\"font-size:15px;margin-bottom:10px\"\u003eTechnical difficulty\u003c\/h3\u003e\n\u003cp class=\"justify\" style=\"color:var(--gv3-ink-2);margin:0 0 14px\"\u003eVery low. There is nothing to install: Cruxi is a browser-based application reached with a Google account or an email and a twelve-character password. The workflow is guided step by step, from administrative contacts through to export, and no development skills are needed since there is no API, no SDK and no integration to configure. The free assessment takes about a minute and needs no account at all. The real effort is regulatory rather than technical: you must describe your device and its intended use accurately and assemble the supporting evidence. Budget four to five hours for the full workflow.\u003c\/p\u003e\n\u003ch3 style=\"font-size:15px;margin:14px 0 10px\"\u003eDeployment\u003c\/h3\u003e\n\u003cdiv class=\"flag-row\"\u003e\u003cspan class=\"flag\"\u003eWeb app\u003c\/span\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"setup-card\"\u003e\n\u003ch3 style=\"font-size:15px;margin-bottom:10px\"\u003eIntegrations\u003c\/h3\u003e\n\u003cdiv class=\"integrations\"\u003e\n\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Google Cloud Platform\u003c\/span\u003e\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e MongoDB Atlas\u003c\/span\u003e\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Google Vertex AI\u003c\/span\u003e\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Gemini\u003c\/span\u003e\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e OpenAI\u003c\/span\u003e\u003cspan class=\"integration\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M6.3 20.3a2.4 2.4 0 0 0 3.4 0L12 18l-6-6-2.3 2.3a2.4 2.4 0 0 0 0 3.4Z\"\u003e\u003c\/path\u003e\u003cpath d=\"m2 22 3-3\"\u003e\u003c\/path\u003e\u003cpath d=\"M7.5 13.5 10 11\"\u003e\u003c\/path\u003e\u003cpath d=\"M10.5 16.5 13 14\"\u003e\u003c\/path\u003e\u003cpath d=\"m18 3-4 4h6l-4 4\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Stripe\u003c\/span\u003e\n\u003c\/div\u003e\n\u003ch3 style=\"font-size:15px;margin:14px 0 10px\"\u003eSupported languages\u003c\/h3\u003e\n\u003cdiv class=\"flag-row\"\u003e\u003cspan class=\"flag\"\u003eEnglish\u003c\/span\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block soft\" id=\"company\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eCompany\u003c\/span\u003e\u003ch2\u003eBehind Cruxi\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"company-grid\"\u003e\n\u003cdiv class=\"company-card\"\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eCompany name\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003cb\u003eTipmunk SASU\u003c\/b\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eFounded\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e29\/12\/2025\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eCountry of origin\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e🇫🇷 France\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eHeadquarters\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e47 rue Vivienne, 75002 Paris, France\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eUBO\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eINFORMATION_NOT_FOUND\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eUBO country\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eINFORMATION_NOT_FOUND\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eDomain registrar country\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e🇱🇹 Lithuania\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"kv\"\u003e\n\u003cdiv class=\"k\"\u003eSupport contact\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e\u003ca href=\"mailto:support@cruxi.ai\"\u003esupport@cruxi.ai\u003c\/a\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"display:grid;gap:14px\"\u003e\u003cdiv class=\"company-card\"\u003e\n\u003ch3 style=\"font-size:15px;margin-bottom:10px\"\u003eSocial\u003c\/h3\u003e\n\u003cdiv class=\"social-row\"\u003e\u003ca class=\"social\" href=\"https:\/\/www.linkedin.com\/company\/cruxi\" target=\"_blank\" rel=\"noopener\" aria-label=\"LinkedIn\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"18\" height=\"18\"\u003e\u003cpath d=\"M16 8a6 6 0 0 1 6 6v7h-4v-7a2 2 0 0 0-4 0v7h-4v-7a6 6 0 0 1 6-6z\"\u003e\u003c\/path\u003e\u003crect x=\"2\" y=\"9\" width=\"4\" height=\"12\"\u003e\u003c\/rect\u003e\u003ccircle cx=\"4\" cy=\"4\" r=\"2\"\u003e\u003c\/circle\u003e\u003c\/svg\u003e\u003c\/a\u003e\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block\" id=\"resources\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eOfficial links\u003c\/span\u003e\u003ch2\u003eResources\u003c\/h2\u003e\n\u003cp class=\"lead\"\u003eAll the official URLs gathered for verification and reference.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"res-grid\"\u003e\n\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cpath d=\"M12 2a14.5 14.5 0 0 0 0 20 14.5 14.5 0 0 0 0-20\"\u003e\u003c\/path\u003e\u003cpath d=\"M2 12h20\"\u003e\u003c\/path\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eHomepage\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/pricing.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"2\" x2=\"12\" y2=\"22\"\u003e\u003c\/line\u003e\u003cpath d=\"M17 5H9.5a3.5 3.5 0 0 0 0 7h5a3.5 3.5 0 0 1 0 7H6\"\u003e\u003c\/path\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003ePricing\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/pricing.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/regulatory\/510k-submission-services.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolygon points=\"12 2 2 7 12 12 22 7 12 2\"\u003e\u003c\/polygon\u003e\u003cpolyline points=\"2 17 12 22 22 17\"\u003e\u003c\/polyline\u003e\u003cpolyline points=\"2 12 12 17 22 12\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eFeatures\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/regulatory\/510k-submission-services.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/company\/about.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003ccircle cx=\"12\" cy=\"12\" r=\"10\"\u003e\u003c\/circle\u003e\u003cline x1=\"12\" y1=\"16\" x2=\"12\" y2=\"12\"\u003e\u003c\/line\u003e\u003cline x1=\"12\" y1=\"8\" x2=\"12.01\" y2=\"8\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eAbout\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/company\/about.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/company\/contact.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003crect x=\"2\" y=\"4\" width=\"20\" height=\"16\" rx=\"2\"\u003e\u003c\/rect\u003e\u003cpath d=\"m22 7-10 5L2 7\"\u003e\u003c\/path\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eContact\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/company\/contact.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/demo-project.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolygon points=\"6 3 20 12 6 21 6 3\"\u003e\u003c\/polygon\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eDemo\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/demo-project.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/legal\/terms-of-service.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M14 2H6a2 2 0 0 0-2 2v16a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V8z\"\u003e\u003c\/path\u003e\u003cpolyline points=\"14 2 14 8 20 8\"\u003e\u003c\/polyline\u003e\u003cline x1=\"16\" y1=\"13\" x2=\"8\" y2=\"13\"\u003e\u003c\/line\u003e\u003cline x1=\"16\" y1=\"17\" x2=\"8\" y2=\"17\"\u003e\u003c\/line\u003e\u003cpolyline points=\"10 9 9 9 8 9\"\u003e\u003c\/polyline\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003eTerms\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/legal\/terms-of-service.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\u003ca class=\"res\" href=\"https:\/\/cruxi.ai\/pages\/legal\/privacy-policy.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpath d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"\u003e\u003c\/path\u003e\u003c\/svg\u003e\u003cdiv class=\"res-text\"\u003e\n\u003cdiv\u003ePrivacy policy\u003c\/div\u003e\n\u003cdiv class=\"url\"\u003ecruxi.ai\/pages\/legal\/privacy-policy.html\u003c\/div\u003e\n\u003c\/div\u003e\u003c\/a\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block\" id=\"faq\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eFAQ\u003c\/span\u003e\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"faq\"\u003e\n\u003cdetails\u003e\u003csummary\u003eWhat does Cruxi actually do? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eIt prepares FDA regulatory submissions for medical devices, with the 510(k) at its centre. Specialised AI agents classify the device, shortlist and score predicate devices, produce a regulatory assessment across all 18 eSTAR sections, draft the content and package the submission. A separate marketplace of more than 25 directories connects companies with regulatory consultants and service providers.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eDoes Cruxi submit to the FDA on my behalf? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eNo. Cruxi never files a submission, never presses submit in eSTAR and never takes a regulatory decision. It produces structured, source-linked drafts that you accept, modify or reject. Accountability for what reaches the FDA stays with you and your designated regulatory owner, and the terms of service exclude legal, medical and regulatory advice.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eWhat does it cost, and is anything free? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eThe quick regulatory assessment is free and needs no account or card, and creating a project after signing in is free. Paid use runs on credits at USD 100 each. A single microservice costs USD 200, the full 510(k) workflow USD 1,000, and a Professional Membership USD 500 per month for 50 monthly credits.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eHow long does a submission take? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eCruxi advertises four to five hours for a complete draft, against six to twelve months of traditional preparation, and claims a 50 to 70 percent reduction in preparation time. That covers your side of the work only: the FDA's own standard review time for a 510(k) remains 90 calendar days.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eAre my confidential device documents used to train AI models? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eAccording to the product FAQ, no. Device information, documents and submission drafts are said to stay within Cruxi's environment and are not used to train public models. The trust centre is more measured and does not claim zero-retention AI processing, and no customer-facing opt-out control is documented.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eWho processes my data? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eCruxi publishes a named subprocessor list: Google Cloud Platform for hosting and file storage, MongoDB Atlas for the database, Google Vertex AI \/ Gemini and OpenAI for AI processing, Stripe for payments, Google Analytics and Tag Manager for measurement, and Google identity services for sign-in. No hosting country or region is published.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eCan I export or delete my data? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eYes. You can export profile, project, workflow, message, consent and privacy-request data as JSON, delete individual projects from the interface and delete your account from the in-app Data and Privacy menu. Formal access, portability, rectification and erasure requests are tracked separately. There is no self-service restore after permanent deletion.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eIs there an API or a mobile app? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eNo. A full review of the site, including a 582-URL sitemap, found no public API documentation, no SDK and no App Store or Google Play listing. Cruxi is a browser-based web application behind authentication, reached with a Google account or an email and password.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eAre all fourteen advertised services available? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eNo. Only the FDA 510(k) is fully open. De Novo, PMA supplements, IDE, Q-Submission, Breakthrough Device Designation, EU MDR technical documentation, UKCA, Health Canada MDL and Australia TGA ARTG are described on the pricing page as in beta and calibration, with access limited to selected groups of professionals.\u003c\/div\u003e\u003c\/details\u003e\u003cdetails\u003e\u003csummary\u003eWho operates Cruxi? \u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cline x1=\"12\" y1=\"5\" x2=\"12\" y2=\"19\"\u003e\u003c\/line\u003e\u003cline x1=\"5\" y1=\"12\" x2=\"19\" y2=\"12\"\u003e\u003c\/line\u003e\u003c\/svg\u003e\u003c\/summary\u003e\u003cdiv class=\"ans justify\"\u003eThe terms of service, the privacy policy and the contact page all name Tipmunk SASU, a French company with a registered office at 47 rue Vivienne, 75002 Paris. A separate Compliance and Contacts page states that Cruxi is headquartered in the United States and not established in the European Union. This contradiction is unresolved on the site.\u003c\/div\u003e\u003c\/details\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003csection class=\"block conclusion\" id=\"conclusion\"\u003e\u003cdiv class=\"head\"\u003e\n\u003cspan class=\"eyebrow\"\u003eConclusion\u003c\/span\u003e\u003ch2\u003eShould you pick Cruxi?\u003c\/h2\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"rich justify\" style=\"max-width:80ch\"\u003e\n\u003cp\u003eCruxi is one of the more convincing vertical AI products of its kind. The scope is real rather than decorative: a complete FDA 510(k) pathway from device intake to an exported submission package, built on an FDA database the company maintains itself, with named agents for classification, predicate scoring and drafting, and source traceability treated as a design constraint instead of a marketing line. The trust documentation is unusually honest for a company this young, stating not only what is protected but what is not. A free assessment with no account makes it cheap to form your own view.\u003c\/p\u003e\n\u003cp\u003eAgainst that sits a set of signals worth resolving first. The site cannot keep its own story straight about where the company is: the terms, the privacy policy and the contact page all describe a French company in Paris, while a compliance page insists Cruxi is headquartered in the United States and outside EU law. The named legal entity and its Paris register number could not be found in the French public registries consulted. SOC 2 Type II and HIPAA are claimed on the homepage and nowhere in the verified-only trust centre. Nine of the fourteen advertised services are still in beta, a promotion that expired in May 2026 was still on display in August, and the 4.8 out of 5 rating is self-declared in the site's own markup.\u003c\/p\u003e\n\u003cp\u003eThe sensible reading is that the software may well be good while the corporate presentation is not yet trustworthy. For a regulatory team that keeps control, has a consultant validate the output and does its own diligence on the vendor, Cruxi is worth the free assessment. For anyone needing certainty about jurisdiction, certification or data location before uploading confidential device files, those answers are not on the site today.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"cta-row\"\u003e\n\u003ca class=\"btn btn-primary\" href=\"https:\/\/cruxi.ai\/\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"16\" height=\"16\"\u003e\u003cpath d=\"M15 3h6v6\"\u003e\u003c\/path\u003e\u003cpath d=\"M10 14 21 3\"\u003e\u003c\/path\u003e\u003cpath d=\"M18 13v6a2 2 0 0 1-2 2H5a2 2 0 0 1-2-2V8a2 2 0 0 1 2-2h6\"\u003e\u003c\/path\u003e\u003c\/svg\u003e Visit Cruxi\u003c\/a\u003e\u003ca class=\"btn btn-secondary\" href=\"https:\/\/cruxi.ai\/pages\/subpages\/regulatory\/510k\/resources\/demo-project.html\" target=\"_blank\" rel=\"noopener\"\u003e\u003csvg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" width=\"14\" height=\"14\"\u003e\u003cpolygon points=\"6 3 20 12 6 21 6 3\"\u003e\u003c\/polygon\u003e\u003c\/svg\u003e Watch the demo\u003c\/a\u003e\n\u003c\/div\u003e\u003c\/section\u003e\n\u003c\/div\u003e","brand":"Tipmunk SASU","offers":[{"title":"Default Title","offer_id":58112661520715,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1038\/0905\/7099\/files\/official-cruxi-by-guidaio_7c8e004a-b7c2-441d-8fe0-d2fa12e2b79f.png?v=1786538636","url":"https:\/\/guidaio.com\/products\/cruxi","provider":"Guidaio","version":"1.0","type":"link"}