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DANIEL WILLIMAN

Regulatory


Daniel Williman has 15 years of experience in the medical device industry. He started his career as a product development engineer and then moved into regulatory affairs leadership roles at Zimmer and DePuy Synthes. Daniel formed his own regulatory affairs consulting business in May 2019, with a goal of helping medical device companies bring innovative products to market and maintain regulatory compliance. More recently, he joined the AcceLINX team as a subject matter expert to assist their clients.

Throughout his career, Daniel has specialized in U.S. and EU regulatory strategy development and execution. He has been responsible for U.S. Pre-Submissions, U.S. 510(k) clearances, U.S. PMA Supplement approvals, a U.S. IDE approval, and various EU Design Dossier approvals and Technical Files.

Daniel’s educational background includes a Bachelor of Science Degree in Bioengineering from the University of Toledo with a minor in Business Administration. He holds a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.