Developing software for medical devices is vastly different than developing other commercial software. In this talk, we will explore how software is regulated, the rationale behind these differences, and how to approach software development for a medical device from a practical perspective while you are in the early R&D phases.

Learning Objectives include

• The basics of wellness software vs. medical device software
• Differentiation between software *in* medical devices and software *as a* medical device
• Standards that govern software
• Software and its relation to risk
• Off-the-shelf software and how to manage it