Virtual Classroom (2 modules): How to Conduct Clinical Investigations with Medical Devices

In the EU member states medical devices were regulated completely different to pharmaceuticals due to different histories, economic reasons and a distinct mode of action. With the new EU medical device regulation the need and requirements for clinical data increased significantly. Consequently, the regulations for conducting clinical trials with medical devices were completely updated. The objective of this training is the communication of current legal, ethical and administrative requirements as well as quality, scientific and practical aspects which are necessary for the conduct of clinical trials with medical devices. This training will support the trainees to increase the quality of your clinical studies in accordance with the regulatory requirements.