Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...

AGAWAM, Mass.--(BUSINESS WIRE)-- A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug ...

"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" is a guide for industry and FDA staff that identifies general factors to consider when validating reprocessing ...