Class III FIH Trial Case Study

AlvaMed was able to support the company’s aggressive timelines to gain study approval and operationally prepare the company to open enrollment in advance of product availability.

IDE Case Study

AlvaMed effectively conducted the IDE study, performed study data cleaning, closure, issued the final study report after meeting the client’s enrollment needs, and received De Novo clearance for the client’s device based on final IDE study report data.

Andre Bessette

The AlvaMed Team played a pivotal role in our early success and the achievement of our key milestone – our First-In-Human clinical experience. Their unwavering support and expertise were instrumental in navigating challenges and driving us forward. We highly recommend AlvaMed as a dedicated and invaluable partner committed to turning visions into reality.

I just wanted to say thanks again for all of the hard (and high quality) work that you’ve done to support BFKW but most recently, getting the BFKW India trial up and running. It seems like it’s been “crunch time” for a while now but the team has pulled it off with the recent formal […]


Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.