Predetermined Change Control Plan (AI-05)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
What it is
the AI/ML Predetermined Change Control Plan — the single document most often cited as the hardest to draft from scratch for AI/ML-enabled devices. Defines in advance which model modifications are pre-authorised, so the model can be updated post-clearance without a new submission. Aligned with both FDA and Health Canada PCCP nomenclature so one plan serves multiple markets.
What it covers
- Description of planned modifications and rationale
- Modification Protocol — data, re-training, evaluation
- Impact assessment of each pre-authorised change
- Acceptance criteria and pre-specified performance bounds
- Transparency and change-communication strategy
- Mapping to FDA and Health Canada PCCP nomenclature
Format
One fully editable Microsoft Word document. Built from public primary sources (FDA and Health Canada PCCP guidance, 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
