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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

ISO 13485 specifies the requirements of a quality management system for medical devices. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 13485:2016/A11:2021 modifies the European standard EN ISO 13485:2016. 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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