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.

Opportunities exist in supporting medical device manufacturers with compliance regarding EO sterilization standards. This includes consultancy on regulatory requirements, assistance in process ...

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 ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

Maintaining a healthy quality system and complying with the Food and Drug Administration’s expectations has never been more important for manufacturers making medical devices bound for the US market.

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 ...

The main market opportunities lie in mastering regulatory decisions for software innovations in healthcare, particularly for digital therapeutics and AI. Navigating complex global regulations ...

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 ...

To simplify and enhance medical device connectivity across health systems, Oracle Health has launched the Oracle Health Device Validation Program for the U.S.—establishing a standardized approach to ...