Dekra — Quality Management System for Medical Devices: ISO 13485:2016

White Paper Dekra (NB 0124) 2023-07-01
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Summary

Dekra’s guide to ISO 13485:2016 Quality Management System requirements for medical device manufacturers. Covers QMS integration with MDR Article 10 obligations, audit expectations, and how to maintain an effective quality system for EU market access.

Document Details

Document IDDEKRA-QMS-13485
TypeWhite Paper
AuthorityDekra (NB 0124)
Publication Date2023-07-01

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TypeWhite Paper
Published ByDekra (NB 0124)
Date2023-07-01

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