The quality management system developed by Askorn had its ISO 13485 : 2016 certificate renewed by the french Notified Body GMED. This certificate is valid until June 14th 2022....
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Guidance for manufacturers of Class I medical devices
💡 The Medical Device Coordination Group has published the MDCG 2019-15 guidance for manufacturers of Class I medical devices. The MDCG recommends the establishement of a quality management system that includes:- A strategy for regulatory compliance,- Identification of applicable general safety and performance requirements,- Responsibility of the management,- Res...