Data Governance & Bias Management Plan (AI-02)

What it is

the deep data governance and bias management plan for an AI/ML-enabled device. The depth-pilot document and the density benchmark for the whole kit, covering how training, tuning and test data are sourced, characterised and kept independent, and how bias is identified and mitigated across the lifecycle.

What it covers

• Data sourcing, provenance and rights
• Representativeness and intended-population coverage
• Training / tuning / test dataset independence
• Bias identification, measurement and mitigation
• Data quality and annotation controls

Format

One fully editable Microsoft Word document. Built from public primary sources (IMDRF GMLP data principles, FDA and 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.