A QA/RA expert available 24/7,
that does not lie
An AI chatbot specialized in medical device regulatory affairs. Plugged into real-time monitoring and a structured knowledge base (MDR, IVDR, FDA, ISO 13485, AI Act). Analyzes your documents. Cites its sources. Honestly acknowledges its limits.
No credit 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
- Documented transition plan
If any of these conditions is not met, the transition applies at the original MDD certificate date or on 26 May 2024.
(Source 1) Regulation (EU) 2023/607 · (Knowledge base) MDR section 1
📎 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
Reinforced anti-hallucination
Structured knowledge base (MDR, IVDR, ISO 13485, FDA, AI Act, MDCG) + real-time RAG. The assistant cites its sources and honestly says when a question exceeds its knowledge.
Real-time monitoring
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.
Your data stays in Europe
AWS Frankfurt hosting, end-to-end encryption. Your attached documents are processed on the fly - they are not 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 real-time monitoring + your documents. It cites its sources and explicitly acknowledges when a question exceeds its knowledge.
What data does it pass to OpenAI or Groq?+
Processing goes through OpenAI (embeddings) and Groq (answer generation). No data is retained by these providers to train models (both APIs have a "zero retention" policy). Your attached documents are processed on the fly then deleted. Your conversations are stored only in your Supabase dashboard, hosted in Europe.
How many questions can I ask per day?+
50 questions/day with a free account, including during the 30-day trial. 200 questions/day with an Independent subscription (€590/year). Unlimited per user with the Company plan.
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. Your documents are stored only in your encrypted Supabase space (AES-256), hosted in Europe. They are neither shared nor used to improve the model. The extracted text is sent temporarily to Groq to generate the answer, under a zero-retention policy.
Ask your first question in 2 minutes
Free account, no credit card, no commitment - plus a 30-day trial to unlock everything. The QARA Assistant is immediately available in your dashboard.
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