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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Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)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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