In order to properly commercialize a software as a medical device application having the right partner who understands how to bring together good software development lifecycle practices, your regulatory profile, and the risks associated with your proposed device is absolutely vital.
At CompliancePath we specialize in making sure that the inflection point where compliance meets quality is always at the heart of our project delivery. Far too many great ideas never make it to market because the foundational steps necessary to achieve regulatory compliance and a successful device approval are often considered too late.