Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK MANAGEMENT – a broad subject

 Spectres  SOCIAL

RISK LIST IMPACT SCALE  Budget  Schedule  Reputation  Health & Safety  Quality  Scope  Security / Data protection  Environment

 POLITICAL  ECONOMIC

 COMMERCIAL  TECHNOLOGY  REGULATION  ENVIRONMENT  SAFETY / SECURITY

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

23

RISK CONCEPTS

Annex C of ISO 14971…

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

24

12