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NBN EN ISO 13485:2016/A11:2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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Summary
Directives : Active implantable medical devices,Medical devices,In vitro diagnostic medical devices,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,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
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 09/10/2021 |
| Page Count | 36 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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26/02/2016
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