Medical Device Software V&V Training Course + SW Documentation Kit Gold

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, model validation and the post-market monitoring that goes with them.

What you get

The course — 2 h 30, four modules

• Where the requirements live: ISO 13485 §7.3, 21 CFR 820.30, IEC 62304, IEC 82304-1
• Safety classification, and the Amendment 1 change that invalidated a common strategy
• Clause 5 end to end, then maintenance, risk management, configuration management, problem resolution
• Validation of a health software product under IEC 82304-1
• Test after each module, final test, certificate of completion
• Software file gap analysis workbook, transcripts, slide handouts

The SW Documentation Kit Gold — 23 templates, three coordinated modules

• Software lifecycle: the complete IEC 62304 set — plan, design, SRS, traceability, SOUP, V&V, release, anomaly log
• AI/ML: lifecycle plan, data governance & bias, model validation, AI risk (AAMI CR34971), PCCP, human oversight & transparency, postmarket monitoring, AI-augmented CEP/CER, SOP
• Cybersecurity: risk assessment & threat model, management plan, vulnerability disclosure policy

One thing worth knowing

The course covers the software lifecycle and the health software product — the first of the three modules in this kit, and the foundation the other two build on. It does not teach the AI/ML specifics: those templates come with their own guidance, and a dedicated course is in preparation.

If your software does not use AI or machine learning, the Course + SW Documentation Kit bundle covers what you need.

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## Note per te — non pubblicare

**Il link nell’ultima riga del Gold** punta a `/product/course-sw-documentation-kit/`. Correggilo con lo slug vero del bundle standard una volta creato.

**Ho scelto di dirlo apertamente** che il corso non copre l’AI/ML. Perdi qualche bundle Gold venduto per equivoco, ma eviti la richiesta di rimborso di chi lo compra aspettandosi il modulo AI e non lo trova. E prepara il terreno al corso successivo, che quel vuoto lo riempie.

**Il modulo 00 gratuito** è dichiarato nella short description del corso. Va reso davvero accessibile: la pagina `/sw-vv/introduction/` deve avere `anteprima: true` nel JSON, che è già così.