Biocompatibility Studies

Ireland division of publicly listed medical device company. The client wanted to write a rationale for biocompatibility for their Transcatheter delivery system based on their previous generation of the same device.

BridgeMed solutions consultant analyzed the project, went through the previous biocompatibility studies, and wrote rationale using previous studies, literature data and historical use of the device. This saved ~$150,000 and 4-6 months of time for the company. In addition the company was able to perform First in Human trial 6 months earlier than anticipated.