What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we will discuss the concept of data sufficiency. Specifically, we will explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer's perspective.
Who is this forum for?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.
|August 3rd, 2022||Watch at a Convenient Time||Recorded|