clinical evidence

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process  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, […]

Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. […]