Supplier Control Archives

A ‘Major Change’: Is Your MedTech Company Ready for FDA’s Review of Audit Reports?

January 1, 2026

The FDA’s new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer’s internal and supplier audit findings

Hurricane, Nuclear Meltdown, Pandemic: This Supply Chain Expert Has Seen It All – See Her 4 Tips For MedTech

October 7, 2025

A veteran MedTech leader has demonstrated exceptional skill in maintaining manufacturing continuity through some of the world’s most challenging supply chain disruptions. Through decisive action,

FDA Investigator Reminds MedTechs: Monitoring of Suppliers Must Include Risk Considerations

May 7, 2025

An FDA investigator emphasizes the critical importance of supplier oversight in medical device manufacturing, warning that poor control remains a common inspection issue. Manufacturers must