Do you have a software solution
with a medical intended purpose?
Simplimedica has extensive experience in Medical Device Software (EN 62304). We have managed CE Technical File, UKCA and FDA submissions for software which is predictive, monitoring solutions, diagnosing and more. Many of our case studies are with start-up solutions who have no idea of the regulatory complications involved in legalising their device for commercial use. With our experience we can advise the best pathway to conformity and very often with less complex solutions to get your Medical Device Software classified and certified. We have dealt with Class I, II and III devices as well as IIa and IIb for UKCA/CE as well.
Below are just some examples of our clients in this sector: