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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In 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....
Read MoreIn pharmaceuticals and medical devices, “quality” is more than a department, it’s the core of the industry. It’s the difference between a life-saving drug and a catastrophic recall, between a trusted medical implant and a...
Read MoreIt’s World Quality Month, and for those of us in Quality, it’s an interesting annual event. Our work, if we’re doing it well, is meant to be invisible. When we do our jobs perfectly, nothing...
Read MoreIn medical device and pharmaceutical manufacturing, we pride ourselves on precision. Our processes are validated, our Standard Operating Procedures (SOPs) are detailed, and our quality systems are designed to eliminate variability. Yet, despite these robust...
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