Newsletters
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 (...)
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 (...)
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 (...)
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. (...)
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 (...)
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Directives 93/42/EEC concerning medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)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 (...)
Over the past decades use of software as a medical device increased exponentially as it undoubtedly helps to improve patient health. In parallel, development and application of regulatory requirements strengthen controls over medical devices specifically medical device software.