We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:
Would you recommend using clinical data from systematic reviews and meta-analyses to support the safety and performance of the subject device?
Do you compare warnings and precautions as part of clinical equivalence?
Can you give an example of a safety/performance objective and corresponding acceptance criteria?
Who should watch this webinar? Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Medical device industry standards are in constant flux. Standards are frequently updated to meet conformity requirements. So what are the clinical requirements that you need to be aware of to stay compliant? (more…)
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