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Posts by Mark D Proulx, CQA, cSSBB

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Mark is an independent consultant and President/Owner of his own Quality and Regulatory company called MLB Marketing, Inc. based out of Florida. He has worked at various levels from small start ups to multibillion dollar, multinational corporations; has multiple college degrees; is a certified Quality Auditor from ASQ; and is a practicing certified Six Sigma Black Belt with over 25 years of experience in Medical Device. An accomplished writer and photographer, Mark has been published nationally and internationally as a contributing author and is recognized for his extensive, on-the-ground reporting of Mississippi immediately after Hurrican Katrina. His photographs of the devastation along the Gulf Coast during 2005-2006 can be seen in Kathleen Koch’s “Rising From Katrina."

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Establishing a QMS

Quality, Fast, Cheap...Pick Two

Mark D Proulx, CQA, cSSBB
February 24, 2019
You may think you're saving the company money by using that "free" Excel spreadsheet to track design. Trust a remediation consultant... you're not. Read More
Establishing a QMS

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

Mark D Proulx, CQA, cSSBB
October 28, 2018
Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Management wonders why we even have quality." Read More

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