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...
Read MoreIn medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...
Read MoreAs 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...
Read MoreIn medical devices and pharmaceuticals, quality isn’t just a department; it’s the foundation of patient safety and organizational trust. For over thirty-five years, my work from the clinical lab to the boardroom has taught me...
Read MoreAs we watch athletes compete in the Winter Olympics, from Alpine skiing to bobsledding, the line between peak performance and physical risk is small. In 2026, technology is not just a training aid; it’s now a...
Read MoreThe FDA’s new Quality Management System Regulation (QMSR) takes effect February 2, 2026, harmonizing with ISO 13485. This shifts the framework from the old, prescriptive QSR to a more proactive, process-based system rooted in risk-management....
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