Module 14 2022

22/03/2022

Suggested further reading ● ISO 13485:2016 – Quality Management Systems ● ISO 14871:2019 + A11 2021 – Risk Management ● Teixiera MB: Design Controls for the Medical Device Industry (2021) ● USFDA: Design Control Guidance for Medical Device Manufacturers (1997 – LATEST VERSION 2018) ● Wiklund M et al: Medical Device Use Error - Root Cause Analysis (CRC Press 2016)

helen@espl-regulatory.com

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