Always up to date: MPDG and EU-V 536/2014
We are expanding our course portfolio!
From now on, we also offer an advanced course for clinical trials of medical devices in addition to the GCP courses. This course is a requirement for the participation in clinical trials of medical devices. It teaches all the relevant fundamentals and is recognized by the Medical Association of Westphalia-Lippe with eight CME points (category D).
The basis of the course is the Medical Device Law Implementation Act (MPDG), which implements the Medical Device Regulation (MDR) in Germany and will come into full force from May 2022. Get an overview of how to conduct clinical trials of medical devices and become an expert in MPDG studies!
Stay up to date with ClinCoach!
We respond immediately to changes in clinical practice. The alterations of the EU Regulation 536/2014, which have been in force since February, are incorporated in all ClinCoach courses. Until recently, the application process for a clinical trial was carried out separately in each member state of the European Economic Area (EEA). However, since 01/02/2022, the EU Regulation 536/2014 applies to all clinical trials conducted in the EU, which newly regulates the procedure for approving a clinical trial and standardizes the approval process.
ClinCoach has incorporated the alterations of the approval process resulting from the regulation in all courses. See for yourself!