Скачать или смотреть Ask the Expert: Clinical Evaluation, Measurable Objectives, and Acceptance Criteria

#clinicalevaluation #safety #performance #acceptancecriteria #CER #MDR #IVDR

This session's topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

This webinar answers questions on identifying meaningful safety and performance endpoints/measures, how to demonstrate that safety and performance objectives are appropriate and relevant, and how to specify acceptance criteria.

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///Who should watch///
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 submissions, or anyone interested in learning more about MDR requirements for CERs.

///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.