AI Risk Management Plan & Report (AI-04)

AI Risk Management Plan & Report (AI-04)

€69.00

SKU AI-04 Category Tags , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

What it is

the AI risk management plan and report. Applies ISO 14971 and extends it with AAMI CR34971 guidance on AI/ML-specific hazards — data drift, automation bias, generalisation failure and related failure modes — coordinated with the rest of the kit.

What it covers

  • ISO 14971 risk management process applied to AI/ML
  • AAMI CR34971 AI-specific hazard categories
  • Data drift, automation bias, generalisation failure
  • Risk controls and residual risk evaluation
  • Benefit-risk linkage to the clinical documents

Format

One fully editable Microsoft Word document. Built from public primary sources (ISO 14971, AAMI CR34971, IMDRF GMLP). 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.

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.