Medical devices are designed by a diverse team. Users are often asked for input on design concepts, however medical professionals often speak a different language than the design engineers creating the products. We are engineers with a lifetime of experience embedded with clinicians - we speak both languages fluently and can bridge the gap for you and your customers.
Medical device manufacturers have used us both before devices are on the market and/or when considering improvements to existing products. Our role is to be an outside technical reviewer with real world perspective in order to supplement the internal design team.
We are able to assist medical device manufacturers prepare a Safety Assurance Case.