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.
Dublin, Feb. 25, 2026 (GLOBE NEWSWIRE) -- The "Process Validation for Medical Devices Training Course (June 4th - June 5th, 2026)" training has been added to ResearchAndMarkets.com's offering. This ...
Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...
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 ...
FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing 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 ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
(MENAFN- GlobeNewsWire - Nasdaq) Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK ...