64 sources monitored continuously, including 49 official authorities - ANSM, Légifrance, MHRA, Health Canada, Swissmedic. Our AI analyzes every publication, summarizes it and tells you exactly what to do.
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Monitoring previewThe 5 most important texts, out of 1,121 alerts from the last 90 days
Order of October 8, 2026 amending the coverage of the in vitro medical device ENDOTEST
DIGICAP: Digitalization of the Medical Device Conformity Assessment Process
Team-NB Position on the Revision of the Regulatory Framework for MDs in the EU
ISO/DIS 81001-1: Principles and Concepts for the Safety, Effectiveness, and Security of Health Software
ISO/DIS 11137-2 in Survey: Sterilization Dose by Irradiation for Health Devices
Monitored sources
Demonstration
The whole journey in ninety seconds: a decree appears in the French Journal officiel, and here is what remains of it when an auditor asks you for it.
A decree in the French Official Journal.
Voice and music · subtitles on screen
Once your scope is declared — two minutes — alerts are filtered to your segments, your standards and your markets.
Features
Not yet another RSS aggregator - a specialist tool that understands your regulations.
An AI chatbot expert in medical device regulatory affairs answers your MDR, IVDR, FDA, ISO 13485 and notified body audit questions. Connected to up-to-date monitoring and a structured knowledge base. Cites its sources, honestly says when it does not know.
ANSM, HAS, Légifrance, MDCG, EMA, FDA, MHRA, Health Canada, Swissmedic, TGA, PMDA, MDSAP and the other sources are collected every 6 hours, from the official feed where one exists and from a news aggregator otherwise. Every alert carries the link to its source.
Every alert is summarized, ranked by criticality (critical / moderate / info) and comes with a list of concrete actions.
Generate timestamped reports ready to file in your quality records - proof of regulatory monitoring for ISO 13485 audits.
Conferences, webinars, regulatory deadlines - never miss a key event in the medical device sector.
France (ANSM, HAS, Légifrance), Europe (MDR/IVDR, MDCG, EMA, EUDAMED) and eleven national authorities of the Member States, United States (FDA), United Kingdom (MHRA), Canada, Switzerland, Japan, Australia, Brazil, Korea, China, India, Mexico, Turkey and ten more countries: 44 of the 47 countries offered have their regulator monitored. Medical device ISO standards are read from the official ISO open data. All in a single dashboard.
Declare your device segments (21 categories), your standards (31 frameworks: MDR, IVDR, FDA, ISO 13485, sterilisation, labelling, IVD, implants…) and your markets from a list of 46 countries. The Alerts page automatically filters on what concerns you.
Hosted in the European Union, encrypted in transit and at rest, processed in line with the GDPR. The QARA Assistant runs on a language model hosted outside the EU: only the documents and questions you submit to it transit there.
Not a generic ChatGPT. A specialist assistant for MDR / IVDR / FDA / ISO 13485 / AI Act, plugged into your up-to-date monitoring, with a structured regulatory knowledge base. It cites its sources and honestly acknowledges its limits.
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.
Structured knowledge base (MDR, IVDR, ISO 13485, FDA, AI Act) and 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.
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.
Your exchanges are saved and resumable at any time. Ideal for preparing an audit over several sessions or building on past analyses.
Free account, no card. The QARA Assistant opens with the 30-day trial, which requires a card and continues as a subscription unless cancelled.
How it works
Sign up in 30 seconds. No card for the free account. Immediate dashboard access.
Our robots scan 64 sources every 6 hours, 49 of them official authorities. Every publication is analyzed, summarized and classified.
Receive alerts by email, check the dashboard, export your PDF reports. Your monitoring is traced and documented.
Why MedQara
A QA/RA engineer spends on average 6 to 10 hours per month manually monitoring regulatory sources. At €50/h loaded cost, that is €3,600 to €6,000/year spent on monitoring alone - with no guarantee that nothing slipped through.
Reclaim 6 to 10 hours a month and keep all 64 sources under watch from €590/year.
Create my accountPricing
Annual billing, cancel anytime. The 30-day trial on the Independent and Company plans requires a card and continues as a subscription at its term, unless cancelled.
Regulatory monitoring takes a QA/RA professional 6 to 10 hours a month - €3,600 to €6,000 a year in loaded cost. Our plans start at €590.
Independent
Freelance QA/RA, outsourced PRRC
Company
Medical device manufacturer or distributor
Consultancy
QA/RA consulting firms and consultants
Two more options
To stay informed: all 64 monitored sources, no alert cap, with a 48-hour delay. No custom scope, no export.
Create a free account →Multi-entity and multi-site, SSO, tailored DPA 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.
Classes I, IIa, IIb and III: the 22 rules of MDR Annex VIII, the implementing rules, special cases and what the class changes for CE marking.
QARA guides
MDR, IVDR, PRRC, EUDAMED, clinical evaluation, vigilance, ISO 13485: every guide is checked against the official texts and kept up to date.
Regulatory affairs
European regulation
EU regulation
Regulatory affairs
Medical software
Regulation
Tools & systems
Regulation
Quality system
Frequently asked questions
It is the continuous monitoring of the texts that govern medical devices: the MDR and IVDR, implementing acts, MDCG documents, harmonised standards, decisions of national authorities such as the ANSM, and export market regulations (FDA, MHRA, Health Canada…). Its purpose: spot in time what changes for your devices and reflect it in your quality system.
Yes. MDR Article 10(9) requires manufacturers to take changes to harmonised standards and common specifications into account in a timely manner, and ISO 13485 requires applicable regulatory requirements to be documented. In an ISO 13485 audit or with your notified body, you must be able to prove this monitoring.
64 sources, including 49 official authorities and institutions: ANSM, HAS, Légifrance, EUR-Lex, the European Commission and MDCG, EMA, EUDAMED, FDA, MHRA, Health Canada, Swissmedic, TGA, PMDA, ANVISA and others, covering the authority of 44 countries. ISO device standards are read from ISO open data.
The free account, with no card and no time limit, gives access to the 64 sources with a 48-hour delay. Annual plans: €590 for an independent professional, €1,990 for a company with unlimited users, €3,900 for a consultancy following up to ten clients.
No. MedQara finds, summarises and ranks publications, and every alert links to the official text. Regulatory decisions remain those of your QARA team, your PRRC or your notified body.
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