Be direct. Be passionate. Be grateful.
For four years now, I have paused around this date to share this story. I do it not for sympathy, but for fidelity, a conscious decision to defy the silence that time imposes. Life often...
Read MoreThe FDA’s New Playbook: Preparing for Inspections Under the QMSR
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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The Art of Change Management: Why Incremental Change Leads to Lasting Transformation
Change is inevitable—but successful change is an art. As a seasoned change agent, I’ve led numerous initiatives, from Quality Management System overhauls to M&A integrations. I’ve studied the theories, applied the models, and navigated the...
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Investing in Women’s health benefits ALL of us
Investing in Women’s health benefits ALL of us For decades, medical research has disproportionately focused on men, leaving critical gaps in our understanding of women’s health. But when we invest in studying conditions that primarily...
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Summer Compliance Checkup: Keeping Your Cool When the Heat is On
Ah, summer—the season of sunshine, vacations, and… compliance headaches? That’s right! While you’re dreaming of beach days and ice-cold lemonade, the medical device and pharmaceutical industries are sweating over temperature spikes, staffing shortages, and supply...
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Printing Electronic Data Doesn’t Solve Data Integrity Issues—Here’s Why
It happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
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Why the FDA’s LDT Rule Was Necessary—Even If the Court Disagreed
An Unpopular Opinion The recent court decision in American Clinical Laboratory Association (ACLA) v. FDA struck down the FDA’s rule regulating laboratory-developed tests (LDTs), ruling the agency lacked statutory authority. While the court was legally...
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