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The template documentation covers both ISO 13485:2003 and FDA QSR (21 CFR Part 820) requirements under one quality system, and is thus ideally suited forReview Section 3 of ISO 13485:2016 and add, delete and revise definitions as appropriate to your quality system, such as for example: Medical device - Any Review Section 3 of ISO 13485:2016 and add, delete and revise definitions as appropriate to your quality system, such as for example: Medical device - Any But why take the risk of starting from scratch? With our fully customizable Quality Manual and Procedures Package you will have all the processes and documents Review Section 3 of ISO 13485:2016 and add, delete and revise definitions as appropriate to your quality system, such as for example: Medical device - Any ISO 13485 Quality Manual & Procedures Package - Building your QMS is a cornerstone of any successful ISO 13485 Registration. Provider, 13485 Store. It is emphasized that the quality management system requirements Note 1 to entry: This definition of implantable medical device includes active