CardioMed Device Consultants

CardioMed Device Consultants is a specialized consulting firm that provides regulatory, pre-clinical, and clinical trial services to the medical device industry. Founded in 2003 and headquartered in Edgewater, Maryland, the company is particularly recognized for its deep expertise in cardiovascular technologies, including stents, heart valves, and drug-device combinations. The firm's team is composed of industry veterans and former FDA reviewers who assist clients with strategic guidance on IDE, PMA, and 510(k) submissions, as well as quality system compliance and bench testing. In October 2024, CardioMed was acquired by the Tentamus Group, integrating its specialized regulatory services into a global network of quality assurance and testing laboratories. The company continues to operate under its established brand, supporting manufacturers through the entire product lifecycle from concept to commercialization.