Standards Archives - QualityHub

QHub Insights║The Evolution of Medical Device Industry Training Requirements

February 24, 2026

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

FDA Adds MedTech Cybersecurity CR to List of Recognized Standards

February 19, 2026

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

MedTech Quality, Manufacturing, Cybersecurity in DOJ’s Enforcement Sights in 2026, Industry Attorney Warns

February 16, 2026

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