Viral Inactivation for TMVR valve

Israel startup medical device company developing class III devices for cardio vascular therapies. The client wanted to write a rationale for viral inactivation studies based on literature data and historical clinical use if the device for First in human (FIH) trail of the class III medical device. The client was a start-up company with limited resources and wanted to perform FIH with minimum expense and in shortest time.

BridgeMed solutions consultant analyzed the project, wrote rationale using literature data and historical use of the device. This saved ~$150,000 and 4-6 months of time for the company.