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Quality

World Quality Day! Being a Quality Pro in Medical Devices and Pharma: Like Being the “Fixer” in an Action Movie
Quality ► November 13, 2024

World Quality Day! Being a Quality Pro in Medical Devices and Pharma: Like Being the “Fixer” in an Action Movie

Ever thought about who keeps the heroes (and sometimes villains) in check in your favorite action movies? That’s right—the fixer, the problem-solver, the behind-the-scenes mastermind helping to ensure everything goes according to plan. In the...

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Ensuring Spooky Season Doesn’t Lead to Scary Outcomes
Quality ► October 14, 2024

Ensuring Spooky Season Doesn’t Lead to Scary Outcomes

Four Key Considerations for Medical Device Quality Assurance in October As October ushers in the festive spirit of Halloween, with costumes, candy, and chilling thrills, this spooky season shouldn’t seep into the world of medical...

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Confessions of a Quality Queen
Leadership ► July 16, 2024

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
Quality ► June 13, 2024

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!
Musings ► May 9, 2024

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
Quality ► April 16, 2024

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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  • Bridging the ISO 13485 to QMSR Gap: The Top 3 Overlooked Issues

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