Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative.
Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality.
“Initiative is to evaluate the opportunity for companies to shift away from being compliance minded and focusing on the true quality of their products and processes.” Jon Speer
“Shape and size is not necessarily a determining factor. It really has been about, ‘What’s in it for me?’, for the companies that are involved.” Jon Speer
“We have companies that want to take shortcuts, or we have people in companies that don’t know what the heck they’re doing.” Mike Drues
“Compliance doesn’t necessarily ensure quality.” Jon Speer
ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:
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...