Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can you do to correct it?
Today’s guest, Mike Drues of Vascular Sciences, and Jon Speer discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS.
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ISO 13485:2016 QMS for Medical Devices
Medical Device Single Audit Program (MDSAP)
MedTech True Quality Stories Podcast
Greenlight Guru True Quality Roadshow
“They weren’t following the procedures. Some of the people didn’t even know that these procedures existed.” Jon Speer
“The procedures that were in place were written in a vacuum. There was no integration, there was no training, there was no transfer of knowledge.” Jon Speer
“The things they were doing, by the intent of the regulation, were compliant. They just weren’t compliant with their own procedures.” Jon Speer
“It’s not the size of the company that matters, it’s the technology.” 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...