SOP - AI/ML Model Development & Lifecycle (AI-09)

SOP – AI/ML Model Development & Lifecycle (AI-09)

€69.00

SKU AI-09 Category Tags , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

What it is

the procedural Standard Operating Procedure for AI/ML model development and lifecycle — the SOP an ISO 13485 quality system requires. Closes the procedural gap between the kit’s plans/reports and a working QMS.

What it covers

  • Scope, roles and responsibilities
  • Step-by-step model development procedure
  • Stage gates and review points
  • Records and traceability requirements
  • Alignment with ISO 13485 §7.5 and GMLP process

Format

One fully editable Microsoft Word document. Built from public primary sources (ISO 13485 §7.5, IMDRF GMLP process structure). 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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Picture of Alessandro Stella

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.