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The Role of a Medical Device Notified Body | BSI America

    https://www.bsigroup.com/en-US/medical-devices/Our-services/What-is-the-role-of-the-Notified-Body/
    The role of a Notified Body and a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) and UK legislation, respectively. The Conformity Assessment usually involves an audit of the manufacturer’s …

Notified Bodies - Public Health

    https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies_en
    A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain …

What is the role of the Notified Body in medical devices

    https://www.bsigroup.com/en-GB/medical-devices/our-services/What-is-the-role-of-the-notified-body/
    The role of a Notified Body and a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) and UK legislation, respectively. The …

Notified Bodies in the European Union: A …

    https://www.compliancegate.com/notified-body/
    Most medical devices require the involvement of a Notified Body. Class I medical devices …



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