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Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)

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Guides

Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance (SSCP) – Regulation (EU) 2017/745

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)

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Application request for CE marking certification – Regulation (EU) 2017/745

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

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Codes assignment referred to in the implementing Regulation 2017/2185 in the context of a request for certification according to the Regulation (EU) 2017/745

Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under (...)

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How to change your Notified Body to GMED in 8 steps

Within the constantly changing regulatory framework and in view of uncertainties regarding the future of certain notified bodies, more and (...)

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Guides

CE Marking of Medical Devices

GMED technical experts developed this valuable guide to help our clients navigate the complex regulations surrounding placing their medical devices (...)

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CE Marking of In Vitro Diagnostic Medical Devices

IVDs (in vitro diagnostic devices) play an important role in the diagnosis and treatment of diseases around the world, including (...)

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