Medical device
regulatory intelligence, finally under control
34 regulators - ANSM, FDA, EMA, MDR, MHRA, PMDA - monitored around the clock. Our AI analyzes every publication, summarizes it and tells you exactly what to do.
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Dashboard· TodayDHPC Mounjaro KwikPen (tirzepatidum) - Utilisation correcte et limitation d'entluftes
EMA : Procédure de consultation pour les substances médicineuses auxiliaires dans les dispositifs médicaux
Avis d'expert EMA sur les DM implantables de classe III et les DM de classe IIb d'administration/retrait de médicaments
Monitored sources
Features
Everything a QA/RA professional needs
Not yet another RSS aggregator - a specialist tool that understands your regulations.
Real-time QARA Assistant
An AI chatbot expert in medical device regulatory affairs answers your MDR, IVDR, FDA, ISO 13485 and notified body audit questions. Connected to real-time monitoring + a structured knowledge base. Cites its sources, honestly says when it does not know.
Near real-time alerts
ANSM, HAS, Légifrance, MDCG, EMA, FDA, MHRA, Health Canada, Swissmedic, TGA, PMDA, MDSAP and 11 more sources analyzed every 6 hours. No critical update slips through.
Actionable AI analysis
Every alert is summarized, ranked by criticality (critical / moderate / info) and comes with a list of concrete actions.
PDF export for your QMS
Generate timestamped reports ready to file in your quality records - proof of regulatory monitoring for ISO 13485 audits.
Built-in QARA calendar
Conferences, webinars, regulatory deadlines - never miss a key event in the medical device sector.
International coverage
France (ANSM, HAS, Légifrance, SNITEM), Europe (MDR/IVDR, EUDAMED, MDCG, EMA), United States (FDA), United Kingdom (MHRA), Canada (Health Canada), Switzerland (Swissmedic), Australia (TGA), Japan (PMDA), international audits (MDSAP, ISO, RAPS) - in a single dashboard.
My scope - tailored monitoring
Declare your device segments (21 categories), your standards (MDR, IVDR, FDA, ISO 13485…) and your markets from a list of 45+ countries. The Alerts page automatically filters on what concerns you.
Data secured in Europe
AWS Frankfurt hosting, end-to-end encryption, native GDPR compliance. Your data never leaves the EU.
A QA/RA expert available 24/7,
that does not lie
Not a generic ChatGPT. A specialist assistant for MDR / IVDR / FDA / ISO 13485 / AI Act, plugged into your real-time monitoring, with a structured regulatory knowledge base. It cites its sources and honestly acknowledges its limits.
- Register your manufacturer SRN
- Submit the UDI-DI/PI of each reference
- Link your valid CE certificates
📎 2 sources used
Analyzes your technical documentation
Upload a technical file, a CER, a PSUR. The assistant analyzes it in light of the latest ANSM, MDCG, FDA alerts and identifies compliance gaps.
Reinforced anti-hallucination
Structured knowledge base (MDR, IVDR, ISO 13485, FDA, AI Act) + real-time monitoring. The assistant cites its sources and honestly admits when a question exceeds its knowledge.
Exportable audit memo
Every conversation can be exported as a timestamped PDF with a source bibliography - usable proof of monitoring for your ISO 13485 and notified body audits.
Conversation history
Your exchanges are saved and resumable at any time. Ideal for preparing an audit over several sessions or building on past analyses.
No credit card. Immediate access to QARA Chat.
How it works
In production in 3 minutes
Create your account
Sign up in 30 seconds. No credit card. Immediate dashboard access.
The AI monitors for you
Our robots scan 34 official sources every 6 hours. Every publication is analyzed, summarized and classified.
Act with full knowledge
Receive alerts by email, check the dashboard, export your PDF reports. Your monitoring is traced and documented.
Why MedQara
Manual monitoring costs 40× more
A QA/RA engineer spends on average 8 to 12 hours per week manually monitoring regulatory sources. At €30/h, that is €14,400/year spent on monitoring alone - with no guarantee of missing nothing.
Reclaim 6 to 10 hours a month and cover 100% of your regulatory sources from €590/year.
Create my accountPricing
The price of a calm audit
Annual billing, cancel anytime. 30-day trial on the Independent and Company plans.
Regulatory monitoring takes a QA/RA professional 6 to 10 hours a month - €4,000 to €8,000 a year in loaded cost. Our plans start at €590.
Independent
Freelance QA/RA, outsourced PRRC
- Unlimited alerts, in real time
- All 34 official sources monitored
- Custom scope: standards, markets, segments
- QARA AI Assistant
- Exportable monitoring evidence (PDF + Excel)
- Email alerts and scheduled digest
- 1 user
Company
Medical device manufacturer or distributor
- Everything in Independent
- Unlimited users within your entity
- Impact analysis and gap analysis on your devices
- Request a new source, standard or market
- Reports with your company logo
- 1-hour setup session with an expert
- Priority support
Consultancy
QA/RA consulting firms and consultants
- Everything in Company
- Up to 10 client scopes
- Co-branded reports with your firm logo
- Recurring commission on referred clients
- Quote and bank transfer billing
Two more options
To stay informed: 3 alerts a week, 3 French sources, 48-hour delay. No custom scope, no export.
Create a free account →Multi-entity and multi-site, SSO, tailored DPA, contractual SLA and centralized billing.
Contact us →Amounts net of tax - VAT not applicable, art. 293 B of the French tax code. The 30-day trial requires a card and converts automatically into a subscription at its term unless cancelled. A PDF quote is provided on request, payable by bank transfer.
Start today
Never miss a regulatory alert again
Join the QA/RA professionals who trust MedQara for their MDR, IVDR and ANSM monitoring.
Free account · No credit card · No commitment
Free weekly digest - no sign-up required
Every week, receive MDR, IVDR, ANSM and FDA alerts summarized and analyzed by our AI. No credit card.
No spam. Unsubscribe in 1 click. GDPR compliant.