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    Actualités

    Category: Non classé

    Publié le 17/06/2019 - Non classé

    ISO 13485 : 2016 certificate renewal

    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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    Catégories

    • Announcement
    • Events
    • Non classé
    • Quality assurance
    • Regulatory affairs

    Recent posts

    • Guidance for manufacturers of Class I medical devices
    • Happy New Year !
    • Design services for patient specific devices
    • The obligations of distributors of medical devices
    • The Essential Requirements of Directive 93/42/EEC become the General Safety and Performance Requirements (GSPR)

    À la une

    Publié le 11/01/2022

    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...

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