Module 14: Design Development and Certification of Medical Devices

17/11/2023

Suggested further reading ◦ ISO 13485:2016 – Quality Management Systems ◦ ISO 14871:2019 + A11 2021 – Risk Management ◦ TeixieraMB: Design Controls for the Medical Device Industry (2021) ◦ US FDA: 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)

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How observant do we need to be?

https://www.youtube.com/watch?v=ubNF9QNEQLA

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