BridgeMedSolutions

Our company is a leading Contract Manufacturing Organization (CMO) in the field of transcatheter heart valves. We customize the production of Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement (TMVR), and Transcatheter Tricuspid Valve (IP) according to customer requirements.Not only do we custom-build valves from scratch (tissue to valve), but we also fill the gap for internal consultants. We provide assistance in various areas such as biocompatibility, ISO 22442, sterilization, viral inactivation certification, QMS, regulatory submissions, and FIH studies. We collaborate with partners to offer stents, delivery systems, and FIH clinical trials to our clients.Our company boasts unique manufacturing, consulting, and strategic service expertise in the medical device field, particularly in transcatheter heart valves. Our specialty lies in tailoring required solutions based on device specifications rather than recommending an entire "nine yards" for any device, thereby saving our clients time and resources.