In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, we will discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We will also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.
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.
|August 31st, 2022||Watch at a convenient time||Recorded|