The Medical Devices Introductory Course 2020

Risk management for Medical Devices & ISO14971:2019 Dr Peter Bowness Technical Team Manager, Medicinal & Biologics Notified Body 0086 (UK) & 2797 (NL) British Standards Institution

The Organisation for Professionals in Regulatory Affairs

Content

1. Introduction 2. Terms & Definitions

3. Regulatory Requirements 4. Risk Management & MDR 5. ISO14971:2019 & TR 24971:2020 6. Content Deviations 7. Common Issues

The Organisation for Professionals in Regulatory Affairs