Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK MANAGEMENT ….

 An important expectation of EU Notified Bodies and the FDA

 Aim – to develop a safe medical device  There is no such thing as an MD without risk

 SAFETY = FREEDOM FROM UNACCEPTABLE RISK

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

9

Regulatory requirements for RISK MANAGEMENT

 You must have…

 An SOP on risk management procedures

 A risk management plan

 A risk register

 Methods for assessing and mitigating risk  Theoretical, actual, potential..

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

10

5