Module 14: Design Development and Certification of Medical Devices

17/11/2023

Regulatory requirement for RISK MANAGEMENT

 MDR 2017/745

 Annex 1 – GSPR: Multiple references to RISK !

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

3

Managing risk

 Risk Management Planning

 Risk Analysis  Tools to help with this

 Risk Management Reporting  Risk Register

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

4

2