Human Oversight & Transparency Plan (AI-06)

Human Oversight & Transparency Plan (AI-06)

€69.00

SKU AI-06 Category Tags , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

What it is

the human oversight and transparency plan. Combines IMDRF GMLP principles P7 and P9, the Transparency guiding principles, and EU AI Act Articles 13 and 14 on transparency and human oversight into one coordinated document.

What it covers

  • Human oversight model and intervention points
  • Information provided to users (EU AI Act Art. 13)
  • Human oversight measures (EU AI Act Art. 14)
  • GMLP P7/P9 transparency expectations
  • User-facing transparency artefacts

Format

One fully editable Microsoft Word document. Built from public primary sources (EU AI Act, IMDRF GMLP, Transparency guiding principles). 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.