Design verification can be a difficult stage for medical device companies to carry out effectively. This is especially true when quality engineers limit their testing activities to only take place during the research and development (R&D) process.
In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls of medical device development.
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Why Design Validation is More Than Testing: How do we validate our validation?
FDA Guidance - Safety and Performance Based Pathway
FDA Premarket Notification 510(k)
MedTech True Quality Stories Podcast
Greenlight Guru True Quality Roadshow
“I would like to think that engineers understand not just how quality should be taken into account, but why it’s so important.” Mike Drues
“Not everything has to be a test.” Jon Speer
“The underlying assumption is that the user knows what they really need. The user knows what the best solution is.” Mike Drues
“Most people are not working on revolutionary devices. They are working on evolutionary devices.” Mike Drues
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...