#clinicalevaluation #safteymeasures #performancemeasures #acceptancecriteria #clinicalbenefits #riskbenefit #datasufficiency
What is this webinar about?
Are you and your team facing one or more critical MDR or IVDR submission deadlines in 2023? In this latest installment in our Ask the Expert series, the writing experts at Criterion Edge answer your questions from their unique perspective - what is required to assemble and write robust, MDR or IVDR reports and submissions to the notified body? The plans and reports required for these regulatory submissions are unique and complex and, in our experience, we often find that the demands and requirements of writing these deliverables can be underestimated by many regulatory and clinical teams.
This webinar aims to help you...
1. Learn what key internal resources are needed for MDR or IVDR readiness.
2. Understand the critical value of starting with an expert gap analysis.
3. Gain insight into how to access he methodology required by the EU MDR and IVDR regulations to write systematic literature reviews.
Who is this webinar 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.
Speaker
Laurie Mitchell
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.