Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together

Time: 3:00 pm
day: Pre-Conference Track 2 PM


  • Defining SaMD, SiMD, Digital Therapeutics, CDS
  • Exploring the different regulatory expectations for each branch to understanding the correct path to market and how to add a new indication depending on your device type
  • Providing background for regulatory expectations – during development, in submission, post market
  • Linking to other important SW regulations as considerations (production, communication to EHR/ MR, AI, Cybersecurity)