Raiana
Raiana is a regulatory affairs assistant for medical devices, in-vitro diagnostics and AI systems. Four specialised chatbots answer on EU MDR, IVDR, FDA rules and the EU AI Act, citing the source texts behind every answer.
What is Raiana?
Raiana is a Dutch AI platform built for one job: regulatory affairs in medical devices, in-vitro diagnostic devices and AI-enabled devices. Its founders read the acronym AI as Augmented Intelligence, and the product is framed throughout as support for a specialist rather than a replacement for one.
At its centre sit four chatbots, each grounded in its own body of law: ChatMDR for the EU Medical Device Regulation, ChatIVDR for in-vitro diagnostics, ChatFDA for United States rules covering both devices and IVDs, and ChatAIAct for the EU AI Act. Every plan includes all four and users switch between them freely, which matters when a European device contains AI or when EU and US requirements have to be compared. Raiana says it works only from current regulations and guidance documents and returns references so answers can be verified, with fine-tuning and rich context used to hold hallucination down. A Verify function goes further: it submits the whole conversation and its cited sources to a second model from another vendor, Anthropic's Claude, which independently checks whether the conclusions hold and whether each reference says what Raiana claims.
Above the chat sit the RAISE apps, short for Regulatory Augmented Intelligence System Executive. They cover incident reportability, rule-based device classification, marketing claim verification against technical documentation, terminology consistency across a whole file, and a standards checklist with gap analysis. MyRaiana stores company and product details so they are reused automatically in chats and apps.
Raiana also travels to where the work happens. A Microsoft Word add-in brings the chatbots into the document being written, using it as context and inserting formatted text directly. An OpenAI-compatible API and a Model Context Protocol server let developers and agents such as Claude or OpenAI Codex call the same regulatory knowledge. The Enterprise tier adds document upload, projects and a dedicated private-cloud server with Microsoft account sign-in. The publisher, Raiana B.V. of Amstelveen, is certified to ISO/IEC 27001:2022.
What it does
- Ask regulatory questions on EU MDR, IVDR, FDA rules or the EU AI Act and get answers with citable references
- Draft and review technical documentation without leaving Microsoft Word
- Store company and product details in MyRaiana and reuse them across chats and apps
- Assess whether a field incident is reportable, by when and to whom
- Produce a rule-based device classification report
- Generate a standards checklist and a gap analysis
- Check terminology consistency and marketing claims across technical documentation
When to use Raiana / When not to
A quick filter to help you decide if Raiana is the right fit.
When to use Raiana
- Regulatory affairs managers and specialists working on EU MDR, IVDR or FDA files
- Independent regulatory consultants juggling several client companies and products
- Quality and QMS managers preparing audits, gap analyses and consistency checks
- Technical writers who draft and review technical documentation inside Microsoft Word
- Manufacturers, notified bodies and large consultancies needing a dedicated private environment
When not to use Raiana
- Anyone looking for formal legal advice, which Raiana states plainly that it does not provide
- Teams working outside the EU/EEA and the United States, as no other jurisdiction is covered
- Users who need a non-English interface, since the product is published in English only
- Entry-level buyers who must upload their own QMS or technical files, a capability reserved to the Enterprise tier
- Organisations that require published contractual terms before purchase, as no terms and conditions page exists
How to use Raiana
A typical end-to-end flow, from setup to results.
- Sign up from the homepage; registration is free and presented as taking about a minute
- Open the portal at portal.raiana.ai, which lists the assistants, the RAISE apps and your API keys
- Pick the chatbot matching your regulation: ChatMDR, ChatIVDR, ChatFDA or ChatAIAct
- Ask your question in plain language and follow the cited references to verify the answer
- Fill in MyRaiana with your company and product details so they are reused automatically
- Trigger Verify when a conclusion is complex, to have a second model re-check answer and sources
- Open a RAISE app for a standing task such as classification, vigilance or consistency checking
- Create an API key in the API keys application and paste it into the Microsoft Word add-in
- For Claude or Codex, download the skill from download.raiana.ai and supply the same key on first use
- For the MCP server, add the Raiana entry to your agent configuration file, with Node.js installed
Pros & Cons
Pros
- Genuine specialisation: four distinct regulatory corpora rather than one general-purpose model
- Answers carry references, so a professional can verify them instead of trusting them
- Unconditional commitment not to train on customer data, written into the privacy policy
- Processing and hosting stated to be exclusively inside the EU, with no third-country transfers
- ISO/IEC 27001:2022 certificate issued by a named accredited body, downloadable in full
- Works inside Microsoft Word, and exposes an API and MCP server for wider integration
- Public pricing with card checkout for the Plus and Pro tiers, plus a 10% permanent SME discount
Cons
- Very young publisher: the company was registered in January 2026, so there is little track record
- No terms and conditions page is published, leaving the contractual scope unverifiable
- The company registration number is not on the site and is only given on request
- Several RAISE apps still carried future availability dates at the time of review
- Sub-processors are acknowledged in the privacy policy but never listed
- File upload and the apps that read files are restricted to the Enterprise tier, whose price is not public
- A Free tier is named only in an unlinked FAQ page and is absent from the pricing page, so its scope is unknown
Pricing & Plans
A free tier exists: the homepage states that signing up to try the product costs nothing, and an FAQ page names a Free plan alongside Plus and Pro, although the pricing page does not describe it. The cheapest paid entry point is Raiana Plus at EUR 29 per user per month, exclusive of Dutch VAT at 21% where applicable. Licences are personal to each user. Annual commitment lowers Plus to EUR 299 per user per year instead of EUR 348, and Pro to EUR 1,299 instead of EUR 1,428. Raiana Pro costs EUR 119 per user per month. Enterprise pricing is not published and is described only as slightly above Pro on a per-user basis.
- named in the FAQ alongside Plus and Pro
- scope not documented on the site
- EUR 29 per user per month
- or EUR 299 per user per year
- 200 questions
- MyRaiana for one company and one product
- Word add-in
- aimed at individual contributors
- EUR 119 per user per month
- or EUR 1
- 299 per user per year
- unlimited questions
- unlimited MyRaiana companies and products
- Word add-in
- RAISE apps without files
- aimed at power users and consultants
- price on request
- unlimited questions and MyRaiana
- Word add-in
- RAISE apps with files
- document upload and a dedicated server
- aimed at manufacturers
- notified bodies and large consultancy firms
Data, GDPR & hosting
A consolidated view of how Raiana handles your data.
GDPR overview
GDPR implementation is documented in concrete terms. The privacy policy, version 1.0 of January 2026, invokes Regulation (EU) 2016/679 from its opening line and names the Dutch supervisory authority, the Autoriteit Persoonsgegevens. It separates controller and processor roles, offers an Article 28 Data Processing Agreement as part of the customer contract, and lists the Article 13 to 22 rights of access, rectification, erasure, restriction, objection and portability, with a one-month response time extendable to two. Personal data is processed exclusively inside the European Union, with no transfers to third countries. Breaches are notified without undue delay. Cookie consent is stated to remain valid for thirteen months. No data protection officer is named and no dedicated privacy mailbox is published: requests go through the website contact form.
Who owns the data?
Customer data stays with the customer. Raiana defines customer data as everything submitted to or processed through its applications, including prompts, uploaded files and generated outputs, and states that this material is neither used for training, fine-tuning or improving models, nor shared with third parties for commercial or advertising purposes. Roles are split: Raiana is the controller for website visits, accounts, subscriptions and billing, and acts as processor when it handles data on a customer's behalf, the customer then being the controller. A Data Processing Agreement under Article 28 GDPR forms an integral part of the customer agreement. Aggregated and anonymised data may be reused for statistics and service improvement.
Reuse rights
Raiana publishes no terms and conditions page, so the only contractual text available is the privacy policy of January 2026. It applies strict purpose limitation: customer data is processed solely to deliver the requested functionality, to comply with the law and to prevent misuse. Benchmarking or evaluating generative models on customer data requires explicit, prior, written opt-in. Data may reach carefully selected sub-processors, such as infrastructure or AI API providers, which are contractually barred from training on it or using it for their own ends; no list of those sub-processors is published. Users keep their inputs and outputs and may request erasure, restriction or portability through the website contact form. Raiana adds that its applications do not give legal advice and that users remain responsible for checking outputs against authoritative regulatory sources.
Data retention & training
Hosting summary
Raiana states that personal data is processed exclusively within the European Union, that all hosting environments, infrastructure and sub-processors are located in the EU and subject to European data protection law, and that no personal data is transferred to third countries. No individual hosting country is named, and no sub-processor list is published. Security measures described include encryption in transit and at rest, role-based access control, segregation of customer environments, logging and incident detection, secure authentication, and incident response and recovery procedures, reviewed periodically. The Enterprise tier goes further, with a dedicated server in a private cloud accessible only to the subscribing organisation. Governing law is Dutch and the supervisory authority cited is the Autoriteit Persoonsgegevens. For completeness, the public marketing site itself resolves to an Amazon Web Services address in Frankfurt, Germany; that is a measurement of the website, not a statement by the publisher about where the platform runs.
Things to keep in mind
Risks and trade-offs to weigh before adopting Raiana.
- Automation complacency is the central risk: answers read fluently and cite sources, which makes them easy to accept without opening the reference that supposedly supports them
- Regulatory judgement can erode with use; a professional who stops reading the underlying texts loses the very expertise the tool is meant to augment
- Raiana states it does not give legal advice and that the user remains responsible, so accountability for a wrong submission stays entirely with the human
- Hallucination is reduced, not eliminated, and the publisher says so; the Verify function mitigates it but is itself an AI check on an AI
- Regulatory texts change, and an answer that was correct at one date may not be at another
- No terms and conditions are published and no sub-processor list exists, so a buyer handling sensitive technical documentation cannot fully audit the chain before signing
- Uploading a full QMS or technical file concentrates highly confidential material in one place, which raises the stakes of any account or password being shared
Setup & Integrations
Technical difficulty
Everyday use needs no technical skill: create a free account, open the portal and start asking questions in the browser. The Word add-in is a middle step, requiring an API key to be generated and pasted into the application, which a video walks through. The MCP server is markedly harder, involving manual editing of an agent configuration file and a working Node.js installation; Raiana concedes the point itself, calling MCP configuration tricky and suggesting you ask a technical colleague. Enterprise deployment adds Microsoft account sign-in, so it involves the organisation's identity directory.
Deployment
Integrations
Supported languages
Behind Raiana
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
Which regulations does Raiana cover?
Is my data used to train the models?
Where is my data hosted?
How much does Raiana cost?
Can one licence be shared across a team?
Is there a free version?
Does Raiana offer an API?
How does Raiana deal with hallucination?
Does Raiana give legal advice?
Is the publisher certified?
Should you pick Raiana?
Raiana is a narrow product aimed at an expensive problem. Regulatory expertise in medical devices is scarce, slow to build and costly to hire, and a tool that answers MDR, IVDR, FDA and EU AI Act questions from the source texts, with references attached, addresses that shortage directly rather than by generic chat.
Two things stand out. The first is the seriousness of the privacy position: an unconditional commitment not to train on customer data, repeated across product pages and written into the privacy policy, processing confined to the European Union, and an ISO/IEC 27001:2022 certificate that names its accredited body, carries a certificate number and is published in full. That is more verifiable assurance than most young vendors offer. The second is reach: the Word add-in, the OpenAI-compatible API and the MCP server mean the tool can be used where regulatory work actually happens, not only in a browser tab.
The weaknesses follow from youth. The company was entered in the Dutch commercial register in January 2026 and the product launched the day before, so there is almost no track record. No terms and conditions are published, the company registration number is given only on request, sub-processors are acknowledged but never listed, and several RAISE apps still carried future availability dates when this record was compiled. A Free tier is named in an unlinked FAQ page but described nowhere.
For a regulatory professional the arithmetic is straightforward: EUR 29 per user per month is modest against the cost of the expertise it supplements. The sensible approach is to treat Raiana as a fast, well-referenced first draft that a qualified person still checks, which is precisely how its publisher describes it.
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