Are you familiar with the substantial regulatory framework changes to In Vitro Diagnostics Regulation? This past October, Criterion Edge’s Director of IVD Writing Services, Dr. Sarah Chavez, presented at the AAMI/FDA/BSI Annual Conference to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Sarah shares and discusses the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track.
Who is this webinar for?
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.
|February 1, 2023
|Watch at a Convenient Time
Takeaways from this session:
Receive helpful suggestions for IVDR planning and preparation
Understand new clinical evidence requirements for IVD
Hear insightful takeaways from the AAMI/FDA/BSI Annual Conference and more!