Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

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 […]
Bridging the Gaps: Clinical Data for GSPRs

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 […]