Module 14: Design Development and Certification of Medical Devices

22/11/2023

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

29

Suggested further reading ● IEC 62304:2006 +AMD1:2015 CSV :

Medical Device Software – software life-cycle processes. ● IMDRF: Post-market clinical follow-up studies, 2010 ● ISO 13485:2016 – Quality Management System ● ISO 14971: 2019 – Application of risk management to medical devices ● Cooper B, ISO 13485 – The quality management systems for medical devices: Understanding quality, risk and design control, 2017. ● US FDA: Postmarket Management of Cybersecurity in Medical Devices, Dec 2016 (updated 2018) ● USFDA: Design Control Guidance for Medical Device Manufacturers (1997)

helen@espl-regulatory.com

© TOPRA and Dr Helen Erwood

The Organisation for Professionals in Regulatory Affairs

ESPL Regulatory Consulting

30

15