Featured Image

Episode 2: Deciphering New FDA Guidance on Software Submissions

  • Posted by Jimmy Townsend and Nathan Viehmann
  • On March 24, 2022
At Engenious, we help medical device R&D leaders create reliable systems quickly. As a result, we develop and test medical device software while navigating regulations and standards that affect software development practices. We are keenly aware that misundestanding FDA’s new guidance on software could cause delays in gaining FDA clearance for new devices. This article […]
Read More