Gen-AI and MLMD Validation & Risk Analysis Pack

Starter 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.

Our experienced team can help you tailor these to your device and organisation, contact us at: www.stjohnlynch.com

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