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 MoreIs Your QMS Haunted? Five Ghosts That Make Quality Hard to Use
Is Your QMS Haunted? Five Ghosts That Make Quality Hard to Use A walk through the procedures that scare your people more than any FDA investigator. Every October, the neighborhood fills up with inflatable ghosts,...
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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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