Dr. Rick Galgon is a Principal Consultant at CardioMed Device Consultants, bringing extensive expertise in medical device regulatory affairs, biomedical engineering, clinical evaluation, electrical safety, and cybersecurity. A former FDA scientific reviewer and board-certified anesthesiologist, he combines clinical, engineering, and regulatory expertise to help medical device manufacturers navigate complex FDA requirements, address technical challenges, and develop effective regulatory strategies. He specializes in complex Class II and Class III devices, with particular expertise in medical device software, cybersecurity, electrical safety, electromagnetic compatibility (EMC), and interventional cardiovascular technologies.
Experience
Dr. Galgon spent six years at the U.S. Food and Drug Administration (FDA) as a scientific reviewer in the Interventional Cardiology Devices and General Hospital Devices Branches. He evaluated a broad range of devices, including angioplasty and atherectomy catheters, intravascular ultrasound systems, embolic protection devices, infusion pumps, vascular access devices, and implantable ports.
During his FDA tenure, he served as a division-level technical resource for electromagnetic compatibility (EMC), medical device software, and magnetic resonance (MR) compatibility. He also contributed to medical device standards development and received multiple FDA recognition awards.
At CardioMed, Dr. Galgon advises manufacturers on regulatory strategy, medical device cybersecurity, electrical safety, EMC, software verification and validation, risk management, device performance testing, and clinical evaluation. His expertise includes cybersecurity risk assessments, FDA cybersecurity documentation, electrical safety testing requirements, and regulatory expectations for connected and software-enabled medical devices.
Dr. Galgon is also a board-certified anesthesiologist and has served as a faculty member in the Department of Anesthesiology at the University of Wisconsin–Madison, with publications in anesthesiology and critical care medicine.