Medical device, defined in the public health code (articles L 5211-1 and R 5211-1), contains very diverse products among which the intrinsic characteristics, the indications and the terms of service can be very variable.
The medical devices are health products which revover from the French Agency of Sanitary Safety of the Health Products (Afssaps) and for which clinical trials are planned by the directives 93/42/CE and 90/385/CE (modified by the directives 2000/70/CE, 2001/104/CE, and 2003/32/CE, modifications which take into account the evolution of the medical devices, in particular those incorporating biological substances).
Due to the diversity of the medical devices, there is no uniform methodology of execution of the clinical studies, what requires an adaptation to the specificities appropriate for every device.
Qualissima leans on its know-how, its experience in the field of clinical trials, and on a perfect control of the regulation of the medical devices and the clinical trials to propose to its partners a complete range of services:
