The updated ISO 9001:2026 standard arrived on Sept. 16, marking the first major revision since 2015 and sharpening its focus on leadership, quality culture, and
With the introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485
The FDA has added AAMI’s CR515:2025, addressing cybersecurity risks unique to machine learning-enabled medical devices, to its list of recognized consensus standards, while cautioning that
The US Department of Justice is intensifying enforcement scrutiny of the medical device sector, focusing on, among other things, product quality, failure to report adverse