Clinical Evaluation Report - AI-Augmented (AI-08b)

Clinical Evaluation Report – AI-Augmented (AI-08b)

€69.00

SKU AI-08b Category Tags , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

What it is

the AI-augmented clinical evaluation report — the reporting counterpart to AI-08a — built on a real CER template with [AI MODULE] markers, documenting the AI clinical evidence and its benefit-risk contribution.

What it covers

  • Clinical evidence summary and appraisal
  • AI-specific evidence flagged as [AI MODULE]
  • Benefit-risk contribution of the AI function
  • Conformance with the CEP (AI-08a)
  • Conclusions supporting the technical file

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.

€69.00

Related products

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.