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 62366-1 · FDA HUMAN FACTORS GUIDANCE · EU MDR ANNEX I IEC 62366-1: Usability Engineering of Medical Devices Thirteen modules that follow the usability engineering process one clause at a time, so you can read a usability engineering file and say what is missing from it. €229 VAT calculated at checkout Get the course…
ISO 14971 · ISO/TR 24971 · ISO/TS 24971-2 · EU MDR / IVDR · EU AI Act Medical Device Risk Management: ISO 14971, ISO/TR 24971 and Artificial Intelligence From the acceptability policy to the post-market loop — each requirement stated precisely, and shown in the document that holds it. €229 VAT calculated at checkout Get…
IEC 62304 · IEC 82304-1 · AAMI CR34971 · MDCG 2019-16 Course + SW Documentation Kit Gold: Software, AI/ML and Cybersecurity The course on how a software file is built, plus the 23 templates that hold the lifecycle, the model and the cybersecurity documents in one coherent set. €929 VAT calculated at checkout Get the…
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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