Process Package — Vigilance Reporting Brazil (Notivisa) Complete framework for Brazilian medical device vigilance. Covers RDC 67/2009 reportability assessment, Notivisa submission, causality classification, foreign event tracking, and field actions. What’s included: SOP-VIG-BR Vigilance Reporting Brazil — full procedure with the 4-question reportability framework per RDC 67/2009, Notivisa submission process, causality classification, timelines (10 days for…
EU AI Act · EU MDR / IVDR · FDA · International Artificial Intelligence in Medical Devices: Regulatory Requirements From qualifying the product and writing an intended purpose that holds, to the evidence a reviewer actually asks for — and everything that has to hold in between. €279 VAT calculated at checkout Get the course…
Article 61 · Annex XIV · Annex XV Clinical Evaluation according to EU MDR 2017/745 From the plan that decides what has to be demonstrated, to the report somebody else assesses — and everything that has to hold in between. €229 VAT calculated at checkout Get the course 13 modules · 3h 23 · workbook…
IEC 62304 · IEC 82304-1 · EU MDR Medical Device Software Verification and Validation What the software lifecycle standards actually require, how the documentation fits together, and what a notified body opens first. €229 VAT calculated at checkout Get the course 4 modules · 2h 30 · workbook · certificateAccess does not expire Most software…
Learn it, then write it The course walks through the software file clause by clause. The kit gives you the documents. Taken together, the workbook you fill in during the course stops being a list of gaps and becomes a list of documents you already have. What you get The course — 2 h 30,…
For software that also uses AI or machine learning The course covers IEC 62304 and IEC 82304-1: how the software is built, and whether the finished product does what it is meant to do. The Gold kit adds what comes on top of that when your device learns — the AI/ML lifecycle documents, data governance,…
Process Package — Vigilance Reporting Japan (PMDA) Complete framework for Japanese medical device vigilance under PMD Act Art. 68-10. Covers the LISTED vs UNLISTED logic (events already in tempu bunsho follow 30-day path; UNLISTED follow stricter 15-day path), causality assessment, mandatory PSB/PSD fax notification for deaths, and tempu bunsho management strategy. What’s included: SOP-VIG-JP Vigilance…
Articles 83–89 · Annex III · US & Australia Post-Market Surveillance Requirements for Medical Devices The surveillance loop end to end — from the plan that starts it to the file that records what it changed. €229 VAT calculated at checkout Get the course 10 modules · 3h 21 · workbook · certificateAccess does not…
Process Package — Vigilance Reporting Australia (TGA) Complete framework for Australian medical device incident reporting. Covers Medical Device Incident Report (MDIR) under TG (MD) Regulations 2002, the Australia-specific exemption mechanism (events that meet specific criteria can be aggregated in Annual Reports rather than reported individually), and the PRAC (Procedure for Recalls, Product Alerts and Product…
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