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Directives 93/42/EEC concerning medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)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