Global Medical Device Podcast Powered By Greenlight.guru
[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)
- Author: Vários
- Narrator: Vários
- Publisher: Podcast
- Duration: 0:40:48
- More information
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Synopsis
In this modern digital world, did you know that most medical devices are not connected to the Internet? 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). Some of the highlights of the show include: - Galen Data’s Goal: Configurable, scalable, FDA-compliant software platform that easily and cost-effectively connects medical devices to an FDA-compliant Cloud. - Check Engine Equivalent: Galen Data’s facilitating staging platform for predictive analytics data and early integration into electronic medical record (EMR). - Input vs. Output: Design and risk controls for mechanical/hardware or software as a medical device are the same. - Design Control and Dev