S5 E7: Academy Talks: Medical Device Documentation: Clinical Studies

We discuss how to define the clinical study endpoints based on your defined safety and performance objectives and the clinical development plan during the clinical validation procedure. We walk through how to design different studies based on available standards and guidelines. Finally we will discuss the importance of the oversight of the clinical investigation and how to do that. We will also touch on the importance of selecting the correct participants and stakeholders to run an efficient and economical clinical investigation.