Thursday, April 24 from 8:40am – 9:40am PT
The integration of device engineering risk concepts into clinical trial risk management activities is advancing at a fast clip. In addition, the identification of pre-defined and pre-quantified safety and performance acceptance criteria has become a required step in clinical evaluations. Putting these concepts together in the work required for clinical trials is new territory for us to explore together.
The ODD couple: Clinical Risk Management via ISO14155 and ISO14971