Appreciating Work Friendships
A Personal Story of Impact & Loss On September 18, 2020, 4 years ago, as a few of my LinkedIn connections know, a close colleague and friend of mine disappeared. One day we were WhatsApp-ing...
Read MoreThe FDA’s New Playbook: Preparing for Inspections Under the QMSR
As of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...
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Playing by the Rules: The Critical Role of Compliance in Olympic Medical Device Use
The health and safety of athletes are super important during any sporting event, especially at the Olympic Games, where the stakes are high, and the competition is intense. In recent years, technological advancements have enabled...
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Confessions of a Quality Queen
It’s my birthday month, and as we typically do , I have taken time to be introspective about where I have been and where I am going. From 2001 to 2020, I was the Head...
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For Father’s Day – An Ode to Deming, the Father of Quality
Happy Father’s Day to all the wonderful fathers out there! In the world of quality management, one name stands out above the rest – Dr. W. Edwards Deming, often regarded as the “father of quality...
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The eternal enjoyment of the QMS update!
It’s 1995, and I’m ready to lead the charge in implementing ISO 13485 and the new Quality System Regulation. I am new to the quality system game, as are we all – it has been...
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Spring Cleaning, Quality Style
Hey, the days are growing longer, and the weather is warming up! It’s time to start thinking about spring cleaning our homes—a fresh start and a declutter! What if we applied this to our work,...
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