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EN ISO 13485:2016/A11:2021 Standard

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  Keywords:

#eu #requirements #relationship #can #regulations

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Tuesday 8th of April 2025

  Description:

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

  Purpose

EN ISO 13485:2016/A11:2021 modifies the European standard EN ISO 13485:2016.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. 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 EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745.— Annex ZB which covers the relationship between EN ISO 13485 and the requirements of Regulation (EU) 2017/746.

  Publication

Wednesday 5th of January 2022

  Amendment

This standard is an amendment for "EN ISO 13485:2016"

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