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
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