Frequently asked questions

MedQara is a SaaS platform for regulatory and technology monitoring dedicated to medical device QA/RA professionals. It automatically aggregates official sources (ANSM, FDA, EMA, MDCG, EUDAMED, RAPS, ISO standards) and uses artificial intelligence to summarize, rank by criticality and propose concrete actions for each alert.

The platform continuously monitors 34 official regulatory sources. France: ANSM, HAS/CNEDiMTS, Légifrance JORF, SNITEM, LNE/G-MED, AFNOR, France Biotech. Europe: European Commission (DG SANTE), MDCG, EMA, EUR-Lex (MDR/IVDR), EUDAMED, NANDO, Medtech Europe. International: FDA (United States), MHRA (United Kingdom), Health Canada, Swissmedic (Switzerland), TGA (Australia), PMDA (Japan), MDSAP, RAPS, as well as the harmonized standards ISO 13485 / 14971 / 62304 / 60601.

The "My scope" area (in the dashboard) lets you declare your device segments (21 categories: IVD, SaMD, implantable, imaging, cardio, ophthalmology, dialysis, etc.), your standards (17 frameworks: MDR, IVDR, FDA, ISO 13485/14971, IEC 62304/60601, AI Act, etc.) and your markets via a drop-down list of more than 45 countries grouped by continent. The "My scope" filter at the top of the Alerts page then only shows the alerts that actually concern you.

Several jurisdictions have their own regulators monitored live: European Union (MDR/IVDR via MDCG/EMA/EUR-Lex), United States (FDA), United Kingdom (MHRA), Canada (Health Canada), Switzerland (Swissmedic), Australia (TGA), Japan (PMDA). By declaring your markets in "My scope", you automatically filter on the corresponding regulatory coverage. Other countries are covered through the ISO/IEC international standards.

Yes. At sign-up, you choose your professional profile (PRRC, manufacturer QA/RA, consultant/firm, hospital biomedical engineer). The recommended actions on each alert are adapted: a consultant receives actions oriented toward client portfolio and impact notes, a PRRC receives actions oriented toward technical documentation and PMS, a hospital biomedical engineer receives materiovigilance and asset-management actions. The AI assistant also adapts to your profile (regulatory QA/RA vs. hospital materiovigilance).

The QARA Assistant is an AI chatbot expert in medical device regulatory affairs (MDR, IVDR, FDA, ISO 13485, MDCG, AI Act). It applies an explicit reasoning method before each answer: understand the question, map the authorized sources (knowledge base + RAG alerts + attached document), cross-reference, assess certainty, then write. It systematically cites the alerts used and clearly states when it does not have the precise information rather than inventing an MDCG number or a date. You can attach a technical document (PDF, TXT, MD) for analysis.

Sources are checked every 6 hours, ANSM/FDA/EMA like the others. Alerts appear on the dashboard in near real time.

Yes. The Free plan is free with no time limit and no credit card: 3 alerts a week, the essential French sources (ANSM, Légifrance, HAS), with a 48-hour delay and no export. Paid plans can be tried for 30 days: a card is required when the trial starts, no amount is charged during that period, and the subscription begins at its term unless cancelled.

Four plans. Independent at €590/year (or €59/month) for the freelance QA/RA or outsourced PRRC: unlimited alerts, all 34 sources, QARA Assistant, exportable monitoring evidence. Company at €1,990/year (or €199/month): unlimited users, gap analysis, requests to add sources, reports with your logo, a setup session. Consultancy at €3,900/year: up to 10 client scopes and co-branded reports. Group on quote. Amounts net of tax, annual billing by default, quote and bank transfer available.

Yes. Cancellation is done in one click from the Settings area ("Manage my subscription" button). No time commitment. You keep Pro access until the end of the paid period, then automatically move back to the Free plan.

Yes. User and monitoring data is hosted in Europe (Supabase / AWS Frankfurt and Render Frankfurt). No data is transferred outside the European Union without standard contractual clauses.

Yes. MedQara collects only the data necessary to provide the service (email, professional profile, notification preferences). Users can export or delete their data at any time via a request to privacy@veillemedqara.fr. A full privacy policy is available from the footer.

Yes. The exportable PDF reports timestamp the alerts consulted and the corresponding analyses. They can be filed in the QMS as proof of structured and traceable regulatory monitoring - an element expected during ISO 13485 and MDR audits.

The MDR (Medical Device Regulation) is Regulation (EU) 2017/745 on medical devices, applicable since 26 May 2021. It replaces Directives 90/385/EEC and 93/42/EEC and imposes reinforced requirements regarding technical documentation, clinical evaluation, post-market surveillance and traceability (UDI, EUDAMED).

The IVDR (In Vitro Diagnostic Regulation) is Regulation (EU) 2017/746 on in vitro diagnostic medical devices, applicable since 26 May 2022. It replaces Directive 98/79/EC and moved about 80% of IVDs under the obligation of notified body assessment, where self-declaration was previously sufficient.

Every medical device or IVD manufacturer, as well as every European authorized representative, must appoint at least one PRRC (Person Responsible for Regulatory Compliance), within the meaning of Article 15 of the MDR or IVDR. Micro and small enterprises may have an external PRRC on a permanent and continuous basis, rather than an employee.

Rule 11 of Annex VIII of the MDR classifies software as a medical device. Software intended to provide information used to make diagnostic or therapeutic decisions is Class IIa by default, IIb if the decision may cause serious deterioration, and III if it may cause death or an irreversible deterioration. This rule moved almost all SaMD to at least Class IIa under the MDR, where they were mostly Class I under the former directive.