The importance of reliability and quality of medical devices cannot be over-estimated, as the lives, safety, and well-being of patients are at great risk and the industry is closely regulated.

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 ...

Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA's own discussions and actions around ...

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 ...

"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 ...

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 ...

Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel ...

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...