NEN-EN-ISO 13485:2016/A11:2021 nl

Current amendment
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33 Pages
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Publication date 2021-09-01
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Dutch
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Medical devices - Quality management systems - Requirements for regulatory purposes
This document amends NEN-EN-ISO 13485:2016 (nl), and replaces NEN-EN-ISO 13485:2016/C11:2017 (nl). EN-ISO 13485:2016/C11:2016 is in The Netherlands implemented as NEN-EN-ISO 13485:2016/C11:2016

Read more in preview and scope
This document replaces:
NEN-EN-ISO 13485:2016/C11:2017 nl
This document modifies:
NEN-EN-ISO 13485:2016 nl
Extra information
Registration date
2022-06-08
Committee
301002
TC
CEN/CLC/JTC 3
ICS code
11.040.01 Medical Equipment In General * 03.100.70 Management Systems
Keywords
Industrial organization - Management systems - Health services - Medical devices

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