The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

Risk Management Plan

V & V

Initiation / Specification

Planning

Design

Development

Production

Preliminary risk assessment

Adapted from ISO 14971:2019 Clause 4.1

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

Risk Management process / procedure

Risk Management policy

Risk Management team assembled

Risk Management plan

Define intended use, user, patient populations, conditions of use

Basic design characteristics

The Organisation for Professionals in Regulatory Affairs