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Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidelines?
In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA.
Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies.
“As part of the Cures Act, we did see that a number of software functions got excluded.”
“That definition in terms of functions is independent of the platform that they run on. So, FDA did a bunch of updates to some of their guidance documents to accommodate that change in definitions around the function.”
“FDA regulates products based on intended use.”
“It’s not necessarily just the functionality, but it’s also how you’ve labeled that functionality that matters. Both things are important.”
“FDA is trying to come into the modern era when it comes to software and how they think about that and how they think about software development.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...