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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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...
Read MoreExploring best practices for quality documentation, employee training, and internal audits of Quality Management Systems
Read MoreAs 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,...
Read MoreIn 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...
Read MoreDeck the halls with boughs of…quality? That’s right! The holiday season is upon us, and while we’re busy spreading cheer and joy, let’s not forget to celebrate the unsung heroes of our industry – Quality...
Read MoreCelebrating Women’s Contributions In today’s dynamic and ever-evolving business landscape, quality leadership is pivotal in ensuring an organization’s success and growth. Effective leadership in quality roles not only enhances product or service quality but also...
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