St John Lynch & Co Ltd

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AI in Medical Devices — Modular Training Programme

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St John Lynch & Co Ltd

Certificate of Completion

This certifies that

has successfully completed the

AI in Medical Devices — Modular Training Programme

A comprehensive modular programme on the regulation, standards and quality management of AI-enabled medical devices — spanning governance, risk management, data management, verification & validation, cybersecurity, human factors and post-market surveillance.

Duration 36 hours · 9 sessions

Training Period January – May 2026

Certificate No.

Niamh St John Lynch

IEC TC62 Expert Member (NSAI) · NSAI ETC/TC10 Chair

Date Issued

St John Lynch & Co Ltd · www.stjohnlynch.com

St John Lynch & Co Ltd

Programme Modules Completed

AI in Medical Devices — Modular Training Programme

Regulations & Standards Overview and Trustworthy AI in Healthcare
Introduction to AI — Overview of AI Model Types
AI Management System (e.g. ISO/IEC 42001)
Pre-Trained Models and Evaluation
Deep Dive into an Example AI-Enabled Device
AI Risk Management
Software Functions for AI — FDA
Software Development Lifecycle & Agentic AI
Predetermined Change Control Plans / Monitoring Plans

EU AI Act 2024/1689 (as amended) + MDCGs
AI Data Management
AI Data Management — PAS, Example Plan & Report
AI Test Methods & Metrics
AI Security Risks and Mitigations
AI in PEMS — IEC 60601-4-1
AI Usability & Human Factors
Performance Evaluation
Post-Market AI Requirements, Maintenance & Change Management

St John Lynch & Co Ltd · www.stjohnlynch.com