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 64 sources, including 49 official authorities and institutions. France: ANSM, HAS/CNEDiMTS, Légifrance JORF. Europe: European Commission (DG SANTE), MDCG, MDR/IVDR harmonised standards published in the Official Journal, EMA, EUR-Lex, EUDAMED, NANDO. National competent authorities: BfArM (Germany), AEMPS (Spain), Ministero della Salute (Italy), AFMPS (Belgium), IGJ (Netherlands), Läkemedelsverket (Sweden), BASG (Austria), INFARMED (Portugal), DMP (Norway), URPL (Poland), ANMDMR (Romania). International: FDA (United States), MHRA (United Kingdom), Health Canada, Swissmedic (Switzerland), TGA (Australia), PMDA (Japan), HSA (Singapore), ANVISA (Brazil), MFDS (South Korea), NMPA (China, English section), CDSCO (India), TFDA (Taiwan), TITCK (Turkey), ANMAT (Argentina), COFEPRIS (Mexico), MDA (Malaysia), SFDA (Saudi Arabia), SAHPRA (South Africa), Medsafe (New Zealand), Thai FDA (Thailand), EDA (Egypt), EDE (United Arab Emirates), AMMPS (Morocco), Kemenkes (Indonesia), Department of Health (Hong Kong), IMDRF, MDSAP, CISA. Alongside them, professional sources that comment on those texts without issuing them: LNE/G-MED, SNITEM, AFNOR, France Biotech, Team-NB, MedTech Europe, BSI, TÜV SÜD, RAPS, PubMed and the specialised press. Finally, the ISO standards of the medical device committees (13485, 14971, 10993, 11607, 15223, 14155, 80369, 15189, 5840…) are read every day from the official ISO open data: publications and drafts under enquiry, including the joint IEC 62366-1, 62304, 81001-5-1 and the 80601 series. The IEC 60601 series alone is not in it: it comes through the European implementing decisions that make standards harmonised, tracked at source.

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 (31 frameworks: MDR, IVDR, FDA, ISO 13485/14971, sterilisation, labelling, reprocessing, cleanrooms, connectors, IVD, implants, AI Act, etc.) and your markets via a drop-down list of 46 countries grouped by continent. The "My scope" filter at the top of the Alerts page then only shows the alerts that actually concern you.

44 of the 47 countries offered have their regulator monitored live: the European Union (MDR/IVDR via MDCG, EMA, EUR-Lex) and eleven national authorities, the United States, the United Kingdom, Canada, Switzerland, Australia, Japan, Singapore, Brazil, South Korea, China, India, Taiwan, Turkey, Argentina, Mexico, Malaysia, Saudi Arabia, South Africa, New Zealand, Thailand, Egypt, the UAE, Morocco, Indonesia and Hong Kong. By declaring your markets in "My scope", you only receive their regulations. Three countries remain covered by the ISO/IEC standards alone, and the interface says so: Israel and Colombia, whose sites refuse automated clients, and Chile, unreachable from abroad.

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 as soon as the collection run ends.

Yes. The Free plan is free with no time limit and no credit card: all 64 monitored sources, with no cap on the number of alerts, a 48-hour delay, no custom scope 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 64 monitored 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: 10 client scopes tracked separately and co-branded reports, extendable by blocks of 5 scopes at +25%/yr. 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 (database in Paris with Supabase, application in Frankfurt with Render, emails sent from Ireland). Only the AI features send text outside the EU, under standard contractual clauses. No other 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 on simple request to contact@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.