AI Development & Lifecycle Plan (AI-01)

What it is

the master AI/ML lifecycle plan that every other document in the kit references. Integrates the IEC 62304 software lifecycle, the IMDRF Good Machine Learning Practice principles and the Health Canada 9-stage ML lifecycle into one coordinated framework that serves five regulatory markets from a single source.

What it covers

• Lifecycle phases and deliverables mapped to IEC 62304
• GMLP principles allocated across the lifecycle
• Health Canada 9-stage ML lifecycle alignment
• Roles, responsibilities and stage gates
• Cross-references to every other document in the kit

Format

One fully editable Microsoft Word document. Built from public primary sources (IEC 62304, IMDRF GMLP, Health Canada guidance). Multi-jurisdictional requirements integrated as inline notes. Instant download after purchase.

Part of the kit

This document is one of 10 in the AI/ML Medical Device Documentation Kit. Buying the complete kit (€499) instead of the 10 documents individually (€690) saves ~28% and adds the README and Excel Master Index.