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UKCA marking: Key steps to consider

The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom Conformity (...)

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Transition to European Medical Device Regulation: Feedback and Challenges to be met

Without providing a full and comprehensive market vision, but based on feedbacks from GMED teams, there is a common denominator (...)

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Biological evaluation: chemical characterization according to EN ISO 10993-18:2020

The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the (...)

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The Post-Market Clinical Follow-up (PMCF) requirements under the European Medical Device Regulation: Step by Step PMCF

The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. (...)

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Introduction to the Regulation (EU) 2017/746

The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)

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Clinical evaluation in the era of Regulation (EU) 2017/745

In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

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MDSAP Program: Principles, Implementation and Advantages

The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)

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Qualification and Classification of Medical Device Software under Regulation (EU) 2017/745

Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient (...)

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