Gen-AI and MLMD Validation & Risk Analysis Pack

A complete set of tools for Validation and Risk Analysis of Generative AI and Machine Learning Medical Devices and Health Software including Gen-AI SOPs, templates, and work instructions aligned to ISO 13485 and applicable for EU MDR, UKCA, and FDA 21 CFR Part 820. Given the absence of regulatory guidance, this pack provides practical frameworks for compliance.

This pack contains:

• Gen-AI Risk Management Plan Template
• Gen-AI Risk Management Summary Report
• Gen-AI Device Risk Management SOP
• Gen-AI QMS Governance SOP
• Gen-AI QMS Computer Software Assurance SOP
• Gen-AI Hazard Register Device
• Hallucination Output Reliability Assessment
• Gen-AI QMS Tool Validation Governance
• Human Oversight Assessment Template
• Gen-AI QMS Computer System Assurance (CSA) Plan & Report Template