Tina Hudson

With over two decades of extensive industry experience, Tina Hudson provides expert guidance to MedTech clients across all aspects of quality, compliance, and clinical support. Beginning her career as an engineer, Tina focused on technical product and process development. She held leadership roles with increasing responsibility in Development, Manufacturing, and Supply Chain at Roche, where she expanded beyond technical efforts to include strategic alliances and business integrations. In transitioning to the startup and mid-tier space, Tina applied her institutional knowledge to help organizations establish and enhance their quality and business infrastructure, building departments and systems from the ground up. As a hands-on leader, she expanded her clinical study development and regulatory submission expertise, supporting both U.S. and international markets. Tina leads ProPharma's MedTech Diagnostic and Combination Product team, helping clients navigate evolving regulatory requirements while remaining focused on business success.

Woman wearing protective equipment looking into microscope

Clinical Research Solutions

Navigating Uncertainty with the FDA LDT Rule

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for...

Continue reading the blog post