Module 14: Design Development and Certification of Medical Devices

17/11/2023

The importance of having sterile devices became clear from the Covid-19 epidemic

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Suggested further reading ● ISO 13485:2016 a11 2021 – Quality Management Systems ● Sterilisation ISOs: 11135, 11137, 17664, 17665, 14937 ● Controlled environment ISOs: 14644, 14698 ● Sterile device packaging ISOs and other standards: 11607, ASTM D4169, ISTA, ASTM F88, ASTM F1140 ● Sterilisation of Biomaterials and Medical Devices Woodhead Publishing series # 46. Ed: Lerouge & Simmons helen@espl-regulatory.com

© TOPRA and Dr Helen Erwood ESPL Regulatory Consulting

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