IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD)

When developing software as a medical device (SaMD), you have to document something called "Software Requirements". That's an ancient term for describing your software features. And there's a standard for that, the IEC 62304 (a lengthy PDF document) which tells you how you document those.

Confused? The good news is that we've developed a software which helps you document those requirements in a compliant way. Watch this video to learn more! :)

Are you interested in shipping your medical software faster? Check out Formwork: