SSI/Medtech- Clinical Evidence Generation

Bringing new technologies and life-altering medical device products to patient populations is complicated and requires high-level strategic detail along with continuous improvement to your processes. Clinical evidence generation is vital to that process.

Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence.