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.

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 ...

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 ...

Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

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 ...

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 ...

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 ...

A well-repeated truism throughout the semiconductor industry is that chip design verification is complex and often takes up the largest portion of a design project’s schedule –– sometimes as much as ...

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv ...