Software and other requirements are critically important to medical device product development.
In this episode, Chris DuPont, co-founder and CEO of Galen Data, provides his best practices for listeners to consider with their medical device product development efforts.
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“The medical device industry tends to lag the technology curve...because of the regulatory burden and overhead.” Chris DuPont
“The most important thing that you can do for any medical device product development effort is have solid requirements.” Jon Speer
“As engineers, we want to build the coolest, most advanced stuff. But you have to take the regulatory pathway into account when making design decisions.” Chris DuPont
“The whole premise of design control...as a means to iterate and evolve. This is not a restriction or impediment to you for making progress.” Jon Speer
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...