The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

Inherent safety by design

Protective measures in the device or its manufacture

Information for safety, such as warnings, etc

ISO 14971:2019 Clauses 7.1 MDR / IVDR GSPR 4

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

The Organisation for Professionals in Regulatory Affairs