Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
YouTube on MSN

The end of checkbox compliance: Aldo Vidinha on the FDA's quality revolution

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
MD&M East

Medtech Implementation of FDA’s Updated QMSR

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
Becker's ASC

Polymicro Technologies Achieves FDA Quality System Regulation Registration, Compliance

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
Pharmaceutical Commerce

Quality and Compliance in the Pharmaceutical Industry: Navigating a Transformed Landscape

Rising recalls, tighter FDA enforcement, global supply chain dependencies, and rapid technology shifts are reshaping pharmaceutical quality and compliance—forcing manufacturers to rethink oversight, ...