The Medical Devices Introductory Course 2020

Terms & Definitions

• Inherent safety by design

• Protective measures in device or manufacture

• Information for safety

The Organisation for Professionals in Regulatory Affairs

Terms & Definitions

Risk Management

•Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk

Identify

Estimate & Evaluate

Monitor

Control

The Organisation for Professionals in Regulatory Affairs