During this Q&A session, our medical regulatory experts discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also explain how to adjust the Clinical Evaluation Plan to align with the regulatory strategy, as well as answer questions about legacy devices, WET devices, and devices exempt from clinical investigations under Article 61.
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.
|September 7, 2022||Watch at a Convenient Time||Recorded|