About a decade ago, when I founded MedDev Soft, after many years of experience as a software engineer and manager at medical companies, I recognized the vast gaps between development and regulatory teams.
Back then, there was one standard and few FDA guidelines which explained how to develop medical software.
But, much has changed since then.
Today, it is impossible to imagine a medical device without software inside (yes, yes, even stents and medical screws are partly software-integrated or partly navigated by software), not to mentioning SaMD, which is a Software as Medical Device itself.
So how do we properly develop medical product software? What is digital health? Does every app uploaded to an app store require regulatory approval? What technology do you use? What is allowed and what is not allowed? How do you protect patients’ information?
These are just a few of the hundreds of questions that come up as you begin to enter the medical software world. When combining software engineering and medical regulation disciplines, things can get confusing.
We at MedDev Soft answer all these questions under one roof. What’s more, we develop using the most advanced technologies in order to provide a holistic solution to your most difficult challenges.
Send me an e-mail email@example.com for an introductory call.