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...
Read MoreThe Best Lessons I Ever Learned Came From a Man With a Meat Cleaver
A Father’s Day reflection on ribs, risk, and raising a quality leader My father could break down a side of beef before most people had finished their morning coffee. He was a butcher, a craftsman...
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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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Quality Training (March) Madness
Maintaining a culture of quality and regulatory compliance is necessary in pharmaceuticals and medical devices. The consequences impact patient safety and organizational reputation and may have legal ramifications. So ongoing training is important, often bordering...
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Love Your Quality System: Navigating the Heart of Medical Device and Pharmaceutical Excellence
Exploring best practices for quality documentation, employee training, and internal audits of Quality Management Systems
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7 Tips for Success in 2024
As we usher in the promise of a new year, the field of quality compliance in medical devices and pharmaceuticals stands at the precipice of innovation, challenges, and boundless possibilities. To seize the opportunities ahead,...
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QSR Transition to QMSR
In early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...
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