Ask the Expert: The Role of RA in the Clinical and Performance Evaluation Report Process

Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. Ask us your questions from any stage of the writing process, from the early planning stage through completion of all required written deliverables. Topics may include early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, or how to identify potential roadblocks and proactively find solutions to common problems.  

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. 

July 13th, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, Ask the Expert: The Role of RA in the Clinical and Performance Evaluation Report Process, fill out the form below.


Questions answered in this session:

  • How to efficiently write a PER?
  • What are key components of the early planning stage that will set you up for success?
  • My team will be working on CEP/CER, postmarket docs, SSCPs. So what is the ideal strategy to plan?
  • & more!
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