Latest Medical Device Industry News & Trends

Medical Device Regulations for SaMD in 2023

June 12, 2023

Let RQMIS help get your SaMD to the European Market.

Evolving GCP Guidelines, Unchanging Principles

June 12, 2023

Overview of the new draft guidance from FDA regarding Good Clinical Practices (GCP).

Are you ready for the eSTAR 510(k) transition?

June 8, 2023

Introducing the FDA's newest submission tool: eSTAR.

FDA Issues Final Guidances for COVID-19 Medical Device Transition Plans

March 27, 2023

UMass M2D2 - April 4th - The Cycle 5 Pitch-Off!!!

March 23, 2023