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EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

General information
Valid from 16.09.2021
Base Documents
EN ISO 13485:2016/A11:2021
Standard history
Status
Date
Type
Name
16.09.2021
Amendment
16.09.2021
Main + amendment
02.03.2016
Main + corrigendum
EN ISO 13485:2016/A11:2021 modifies the European standard EVS-EN ISO 13485:2016. EVS-EN ISO 13485 specifies requirements of a quality management system for medical devices. The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history. EVS-EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes. In this amendment you can find: — Annex ZA which covers the relationship between EVS-EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745. — Annex ZB which covers the relationship between EVS-EN ISO 13485 and the requirements of Regulation (EU) 2017/746.
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