Change is constant… Especially in the medical device industry. Medical device change management can be a challenging concept and process for companies, especially during FDA inspections and other audits from regulatory agencies.
Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the twists and turns of what to expect, what you may experience, and what to focus on when dealing with change management.
“The word, ‘change,’ has a very broad connotation. It could be a change to the design, material, manufacturing method, cosmetic change.” Mike Drues
“Changes will happen.” Jon Speer
“Many companies are following the ‘industry standard.’ Just because it is the industry standard, doesn’t mean that it is correct.” Mike Drues
“Companies should not fear making changes to devices, simply because they don’t want to deal with the FDA.” Mike Drues
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...