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
In this QualityHub Brief, pharma companies are introduced to the unique regulatory and manufacturing challenges associated with developing combination products, even when using standard delivery
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 FDA described in a Town Hall webinar how medical device inspections under the Quality Management System Regulation (QMSR) emphasize a flexible, risk-based approach
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
Three QualityHub subject matter experts discuss the US FDA’s updated Compliance Program Manual for MedTech, which gives medical device manufacturers a roadmap of inspection priorities
This QHub Expert White Paper for MedTechs identifies areas that commonly signal weaknesses in Quality Culture, explains strategies for improvement, and provides actionable recommendations for
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 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