In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next, using our CE Scoping checklist, we will walk through the essential IVDR documents. Additionally, we’ll discuss SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.
Click here to watch the recording of this webinar.
Watch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR?
Key takeaways from the discussion include:
All regulatory, clinical, and scientific professionals who develop, write, review, or approve scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.
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