Module 14: Design Development and Certification of Medical Devices

17/11/2023

Risk Assessment and Risk Management

ISO 14971: 2019

MEDICAL DEVICES

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

1

Legislation

 ISO 14971: 2019 : risk management

 The EU MDR (2017/735) and UK Medicines and Medical Devices Act 2021

 FDA 21CFR 820.30: Quality system regulation

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

2

1