Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Process Validation for Medical Devices (June 4th - June 5th, 2026)" training has been added to ResearchAndMarkets.com's offering. Process validation is ...

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 ...

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 ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

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 ...

Sterile-device regulations are driving demand for process validation, sterility controls, barrier systems, third-party assessments and compliance training.Dublin, Sept. (GLOBE NEWSWIRE) -- ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Bryan Campbell, plant manager at Mack Molding's headquarters facility in Arlington, VT, penned an article on the topic for our sister publication MDDI (Medical Device and Diagnostic Industry).

Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it's a legitimate engineering discipline with specific, defensible use cases: replacing ...