The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

Would a user recognise the error Would a user know what to do if they did

Detection not always advisable Risk = severity x likelihood RI = risk index

RI helps understand the most significant risks

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

The Organisation for Professionals in Regulatory Affairs