In this modern digital world, did you know that most medical devices are not connected to the Internet? That will soon change though, thanks to the emergence of software as a medical device.
In this episode of the Global Medical Device Podcast is a special live recording from The Greenlight Guru True Quality Roadshow in San Jose, California and is moderated by Tom Rish, Medical Device Guru at Greenlight Guru. Chris DuPont, CEO of Galen Data, joins Tom as his guest to discuss with live viewers and podcast listeners the design control and development process for software as a medical device (SaMD).
“Most medical devices today are not connected to the Internet.”
“What’s difficult about software is it’s malleable. It can change over time.”
“Where we make mistakes is when we miss requirements.”
“As engineers, we like to build the biggest and coolest thing. But you have to consider the regulatory pathway.”
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The Global Medical Device Podcast powered byGreenlight Guruis 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...