Clinical Evaluation Plan – AI-Augmented (AI-08a)

What it is

an AI-augmented clinical evaluation plan built on a real CEP template, with AI-specific additions clearly flagged as [AI MODULE] so the AI evidence strategy integrates cleanly with your existing clinical evaluation process.

What it covers

• Clinical evaluation scope and method
• AI evidence strategy flagged as [AI MODULE]
• Clinical data sources and appraisal plan
• Integration with the standard CEP structure
• Link to the AI-Augmented Clinical Evaluation Report

Format

One fully editable Microsoft Word document. Built from public primary sources (MDR Article 61, IMDRF GMLP clinical 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.