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Medical devices - standards and support services | BSI

    https://www.bsigroup.com/en-GB/medical-devices/
    Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and …

Meet requirements of EU Medical Device …

    https://www.bsigroup.com/en-US/medical-devices/Our-services/CE-marking/
    BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and …

General Safety and Performance …

    https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/general-safety-and-performance-requirements/
    Annex I in the New Medical Device Regulation This paper provides comparison of the Safety and Performance Requirements (SPRs) of the new Medical Devices Regulation (MDR) and the Essential …

Technical Documentation and Medical Device …

    https://www.bsigroup.com/contentassets/c48f4dd0aa8d4042987a2fbe72c3e086/white_paper__technical_documentation_web_v3.pdf
    Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant …

European complying with the Medical …

    https://www.bsigroup.com/en-IN/Medical-Devices/Our-services/European-Medical-Device-Directives/
    Gain market access in Europe by complying with the Medical Device Directives. The Medical Device Directives are 'New Approach' directives relating to the safety and performance of medical …

Medical Devices Industry Guidance and Resources | BSI …

    https://www.bsigroup.com/en-US/medical-devices/Resources/Industry-guidance-and-resources/
    As an accredited certification body, BSI Assurance cannot offer certification to clients where they have also received consultancy from another part of the BSI Group for the same …

BSI Training - Medical Device Directive (MDD) to …

    https://bsi.learncentral.com/shop/Course.aspx?id=25673&name=Medical+Device+Directive+(MDD)+to+Medical+Device+Regulation+(MDR)
    BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner …

BSI Training - Medical Device Directive (MDD) to …

    https://bsi.learncentral.com/shop/Course.aspx?id=24648&name=Medical+Device+Directive+(MDD)+to+Medical+Device+Regulation+(MDR)
    BSI Training - Medical Device Directive (MDD) to Medical Device Regulation (MDR) Announcing BSI's ISO/IEC 27001:2022 Virtual Transition Training Course Details Medical …



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