Changing technologies and methods blur the demarcation between devices and medicine
The safety and efficacy of medical devices are increasingly regulated in parallel to regulations governing pharmaceuticals. However, with changing technologies and advances in the ways devices are used, the demarcation between medical devices and medicine is becoming increasingly blurred.
ZEG Berlin’s study approach can efficiently evaluate the post-market efficacy and safety of medical devices, including prompt evaluation of emerging safety concerns. We have previously conducted studies assessing implantable medical devices and in collaboration with you, can develop a study that suits your needs.