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Askorn
44c, rue de Bray
35510 Cesson-Sévigné
France
Phone : +33 (0)2 23 35 53 35
Fax : +33 (0)2 23 35 16 35
Mail : contact@askorn.bzh
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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...