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 ...

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...

Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.

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 ...

Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...

(MENAFN- GlobeNewsWire - Nasdaq) Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK ...

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 ...

Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...