Litigation Archives - QualityHub

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

QHub Insights║20 Years On, Outcome of FDA v. Utah Medical Still Reverberates, Say Investigator, Lawyer Involved In 2005 QSR Case

October 29, 2025

Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP