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How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions
In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation prior to submission to regulatory authorities.

Key Takeaways:
• Strategically review a CER for clearly stated purpose statements, clear documentation of methodology and logical flow and organization
• Assess your CER for MDR alignment by reviewing for common gaps found in: Clinical Data Sources like Clinical Literature and Post-Market, Surveillance and Clinical Investigations, and Risk-Benefit Analysis

Who should attend?

All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.

Do you feel like you need more time or guidance before submitting to regulatory authorities? Check out our other MDR webinars in this series: https://go.criterionedge.com/l/265652/2021-04-09/k53ng

May 12, 2021 11:00 AM in Pacific Time (US and Canada)

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Speakers

Laurie Mitchell
President @Criterion Edge
Laurie Mitchell is Founder and President of Criterion Edge, a global medical and regulatory writing and safety services firm serving the medical device, pharmaceutical, and biotech industries. Laurie has over 20 years of experience in medical writing, safety and pharmacovigilance management, and regulatory reporting. Having provided regulatory solutions to many pharma and medical device companies, both large and small, she is a proven leader in designing practical strategies to meet current global regulatory challenges. Laurie is a published author and holds a Master of Nursing from UCLA.