DIRECTOR OF REGULATORY AFFAIRS
Joined: April 29, 2024
I am a Medical Device Quality and Regulatory Affairs consultant with a history of working on diverse products within the medical device industry. I have supported 510(k) clearance for over 30 different medical devices, and have helped dozens of companies achieve their Quality and Regulatory goals. My experience spans many different technologies including SaMD (Digital Health, Mobile Apps, AI/ML Contouring, Computer Aided Detection/Diagnosis/Triage), In Vitro Diagnostic Devices, Reprocessed Devices, Electromechanical Devices, Implants, Dental Products, Surgical Planning, Surgical Tools, and more. My technical background is in engineering product development with a degree focused in Biomedical Engineering.
Camping, Watersports, Cooking, Teaching