This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, we will answer questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process.
During this session, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.
This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.
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 or performance evaluation reports for IVDR submissions.