A QA/RA expert available 24/7,
that cites its sources
An AI chatbot specialized in medical device regulatory affairs. Plugged into up-to-date monitoring and a structured knowledge base (MDR, IVDR, FDA, ISO 13485, AI Act). Analyzes your documents. Cites its sources. Honestly acknowledges its limits.
Free account, no card · No commitment · Immediate answer after sign-up
For a non-implantable Class IIa, the extension provided by Regulation (EU) 2023/607 runs until December 31, 2028, under cumulative conditions:
- Application submitted to a notified body before 26 May 2024
- Formal NB agreement before 26 September 2024
- No significant change to the device
- Quality management system under Article 10(9) in place by 26 May 2024
If any of these conditions is not met, the extension does not apply: the MDD certificate ceases to have effect on its expiry date.
Sources: Regulation (EU) 2023/607 · MDR, Article 120
📎 1 source used · Exportable audit memo
Use cases
Built for a PRRC's daily work
Four situations where the QARA Assistant saves you hours.
Technical file audit before the NB
Upload your Technical File, CER or PSUR. The assistant identifies gaps in light of the latest ANSM, MDCG, FDA alerts.
Express MDR / IVDR / FDA question
An answer in seconds, sourced from the structured knowledge base or the platform’s latest alerts.
PMCF / PMPF preparation
Brainstorm objectives, study design and a methodology acceptable to your NB, in light of the most recent MDCG documents.
Medical device cybersecurity watch
Cross-referencing IEC 81001-5-1, FDA Cybersecurity Guidance 2023, AI Act Articles 8-15 for your connected devices.
Guarantees
What makes it different
Sourced answers
Structured knowledge base (MDR, IVDR, ISO 13485, FDA, AI Act, MDCG) and RAG over up-to-date monitoring. Every answer points back to the texts it rests on, and the assistant says so when a question exceeds what it knows.
Indexed in under 30 seconds
As soon as the collection run ends, every new ANSM, EMA, FDA or MDCG alert is embedded and available to the chatbot in under 30 seconds.
Cited, clickable sources
Every answer cites its sources with a direct link to the original alert (official PDF, authority page, etc.).
ISO 13485 audit memo export
Every conversation can be exported as a timestamped PDF with a bibliography - usable proof of monitoring for your NB and ISO 13485 audits.
Where your data goes
Your account and your monitoring data are hosted in the European Union, encrypted in transit and at rest. The assistant runs on a language model hosted in the United States: your questions and attached documents transit there, processed on the fly and never reused to train models.
Available 24/7
No waiting, no appointment. The assistant answers instantly, in a professional and factual tone.
Frequently asked questions
QARA Assistant FAQ
How is the QARA Assistant different from ChatGPT?+
ChatGPT is a general-purpose model that notoriously hallucinates on regulatory references (invented MDCG numbers, approximate dates, wrong articles). The QARA Assistant is medical-device specialized: it relies on a structured knowledge base (MDR, IVDR, ISO, FDA, AI Act) + the platform’s up-to-date monitoring + your documents. It cites its sources and explicitly acknowledges when a question exceeds its knowledge.
What data does it send, and to whom?+
Answers are written by Anthropic (Claude) or, as a fallback, by Groq; OpenAI turns your question into a search vector. They receive your question, the current conversation, the text of any attached document, your role, your scope and up to 15 of your declared devices. Never your name, your email or your billing data. Their API terms exclude training their models on this content. Your conversations are kept in your space, hosted in Paris, and you can delete them at any time.
How many questions can I ask per day?+
50 questions/day during the 30-day trial, which starts when the account is created. 200 questions/day with an Independent subscription (€590/year). Unlimited per user with the Company plan. The Assistant is not included in the free plan once the trial ends.
Can it analyze a PDF larger than 5 MB?+
The current limit is 5 MB per document, and the extracted text is capped at about 9,000 characters in the analysis context. For large technical files, you can split them into sections (CER, PSUR, PMCF plan, etc.) and ask targeted questions about each part.
Can the assistant replace my notified body?+
No, and it does not claim to. The QARA Assistant is a decision-support and monitoring tool. Any decision affecting a device in production must be validated with your notified body or an accredited QA/RA expert. This is reminded in every conversation and in the exported PDF memo.
Do my technical documents stay confidential?+
Yes. An attached document is not kept: its text is extracted, sent to the model for the time of the answer, then forgotten. It is neither shared nor used to train a model.
Ask your first question in 2 minutes
Free account, no card, no commitment. The 30-day trial that unlocks everything requires a card and continues as a subscription unless cancelled. The QARA Assistant is immediately available in your dashboard.
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