The FDA’s Quality Management System Regulation has shifted medical device quality systems from procedural compliance to a stronger focus on risk-based decision-making supported by clear,
Early FDA inspection data under the new QMSR framework points to persistent weaknesses in how companies manage risk, oversee suppliers, investigate complaints, maintain UDI compliance,
A QualityHub SME says medical device companies must move beyond treating risk management as a compliance exercise and instead adopt dynamic, continuously updated approaches informed
At an April 1 Town Hall, the US Food and Drug Administration outlined updates to its medical device inspection approach under the Quality Management System
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
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
With the FDA’s Quality Management System Regulation coming into force on Feb. 2, medical device makers face heightened pressure to strengthen risk management practices as
QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and
User-related errors in medical device use are a critical focus in risk analysis, where human factors engineering aims to minimize these errors through intuitive, user-centered