Speaker: Sabrina Varanelli, Founder & CEO, Nemedio

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 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