DEVICE L❤️VE Live! #13 — July 16, 2020

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Is this software application a medical device?


DEVICE L❤️VE Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. The panelists also answer audience questions. Every episode is added to our podcast, too.

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It can be difficult to keep software clear of being classified as a medical device when used in healthcare. For example, wellness apps are frequently on the fence, and with every added feature you need to reassess the intended use to ensure you haven't crossed the line into medical device territory.

When a software application is used in conjunction with a medical device, it's even more challenging to keep the app clear of being a medical device itself. Regulatory professionals feel the pressure of software developers and marketers who want the speed to market that's needed to win in this competitive environment.

Most of us in regulatory affairs have been asked by our product development teams questions like,

  • "This new app isn't a device, right?"

  • "Even though the app talks to a device, how can we keep the app from being a device?"

  • "Does the app really need to comply with design controls? It's not really a device, is it?"

In this show we'll discuss:

  • Elements of software and intended use that trigger medical device requirements

  • Process for making a determination, tips on steering clear of a device classification, and examples on both sides

We encourage you to bring your questions! We'll be answering live.

Here's the panel:

  • Nancy Morrison, RAC — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q

  • Carol Vierling, RAC — Senior Principal Advisor, Consulting Services, R&Q
  • Jessica Andreshak — Senior Principal Specialist, R&Q
  • Chad Quistad — Principal Engineer, R&Q