Latest Medical Device Industry News & Trends

Evolving GCP Guidelines, Unchanging Principles

June 12, 2023

Overview of the new draft guidance from FDA regarding Good Clinical Practices (GCP).

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

June 8, 2023

Introducing the FDA's newest submission tool: eSTAR.

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

March 27, 2023

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

March 23, 2023

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EU MDR News! Extension proposal!

December 9, 2022

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