A strong Culture of Quality in medical device companies is demonstrated through leadership actions and employees’ willingness to raise concerns, among other factors, rather than
QualityHub has appointed medical device quality executive Christina Arnt as Vice President of Medical Device Compliance. Arnt brings extensive global quality systems leadership experience from
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
The FDA’s new Quality Management System Regulation makes quality culture a top management responsibility, and regulators will increasingly look for objective evidence that quality is
Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP