[FREE WEBINAR] Plain Language Communication in Healthcare Part 1 Webinar
Click here to watch the recording of this webinar. Medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for […]
[FREE WEBINAR] New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
Click here to watch the recording of this webinar. The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for […]
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 […]
