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SSH EN ISO 13485:2016/A11:2021

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

Aug 29, 2022

General information

60.60     Aug 29, 2022

DPS

DPS/KT 316

European Norm

03.100.70     11.040.01  

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Scope

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Related directives

Directives related to this standards.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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Life cycle

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PUBLISHED
SSH EN ISO 13485:2016/A11:2021
60.60 Standard published
Aug 29, 2022

Related project

Adopted from EN ISO 13485:2016/A11:2021

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