Michael Yan

He specializes in regulatory strategy development, clinical trial management, and quality system implementation across a wide range of technologies, including surgical robotics, radiology systems, wearable devices, and AI-based software. Yan has successfully guided start-ups and multinational manufacturers through regulatory pathways for FDA, EU MDR, and China NMPA. At Pure Global, he provides strategic regulatory consulting that helps clients navigate international compliance challenges, optimize submissions, and accelerate time to market.

Yan’s background includes leadership roles at Medtronic, Varian, Brainlab, and Qserve Group. He holds degrees in Pharmacy and International Trade and is a certified member of the Regulatory Affairs Professionals Society (RAPS).