- ISO Medical devices — Quality management systems – Requirements for regulatory purposes; ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk.
- BS EN ISO,Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes (British Standard) BS EN ISO PDF can be downloaded free of charge on this website.BS EN ISO replaces BS EN ISO. This International Standard.
Free ISO 13485 Quickstart Guide
ISO specifies more detail than 21 CFR 820 and addresses competence as opposed to training e g competence via education skills experience 21 CFR 820 specifies requirements for 1 personnel performing verification and validation activities and 2 21 CFR 820 states that personnel shall be made aware 26-Nov-20200 Views15 Pages.
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