AI/ML Medical Device Documentation Kit – Complete Bundle

What it is

The complete AI/ML technical documentation set in one coordinated package, structured to serve five regulatory markets from a single source. Ten professionally drafted documents covering the full AI/ML lifecycle expected by FDA, the EU AI Act and MDR, Health Canada, Australia’s TGA and Brazil’s ANVISA, with the IMDRF Good Machine Learning Practice principles as the convergent spine.

What is included

• AI Development & Lifecycle Plan — IEC 62304 + GMLP + Health Canada 9-stage lifecycle
• Data Governance & Bias Management Plan — sourcing, representativeness, bias mitigation
• Model Validation & Performance Report — standalone + subgroup performance
• AI Risk Management Plan & Report — ISO 14971 + AAMI CR34971 AI hazards
• Predetermined Change Control Plan (PCCP) — FDA + Health Canada nomenclature
• Human Oversight & Transparency Plan — GMLP P7/P9 + EU AI Act Art. 13–14
• Postmarket AI Performance Monitoring — drift, logging, re-training triggers
• Clinical Evaluation Plan — AI-Augmented — built on a real CEP template, [AI MODULE] markers
• Clinical Evaluation Report — AI-Augmented — built on a real CER template, [AI MODULE] markers
• SOP — AI/ML Model Development & Lifecycle — ISO 13485 §7.5 procedural SOP
• Master Index spreadsheet (5 sheets) + README with usage instructions

Format

9 Microsoft Word documents (fully editable) + 1 Excel Master Index & Conformity Matrix. Multi-jurisdictional requirements integrated as inline notes throughout. Built entirely from public primary sources (FDA, IMDRF GMLP, Health Canada, EU AI Act, ISO 13485 §7.5). Delivered as a single ZIP. Instant download after purchase.

Need cybersecurity documentation too?

AI/ML-enabled devices typically also require a medical device cybersecurity file. Pair this kit with the Cybersecurity Documentation Kit — sold separately.