The Medical Devices Introductory Course 2020

ISO 14971: 2019 Overview

Risk management as per ISO 14971 is:

Initial conception, design, development

a systematic approach to identify, assess, control and monitor all risks associated with the medical device throughout its life cycle

Production, distribution, installation, use, service, maintenance Post-production (after market introduction), decommissioning, disposal

The Organisation for Professionals in Regulatory Affairs

ISO 14971: 2019 Overview

• Fundamental understanding and process for risk management has not changed

• Multiple stakeholder perspectives exist and need to be considered

• ISO 14971 is focussed on product safety risks not organisational or business risks

The Organisation for Professionals in Regulatory Affairs