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 ...

The Medical Validation Procedure is very critical to verify that the system offers repeatability, assurance of accuracy, and a high degree of quality, according to a release from MTMS. The company ...

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 ...

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.

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 ...

In the lab, innovation drives the development of new technology to expand research and overcome technical challenges in healthcare, pharmaceuticals and beyond. Automation is revolutionizing ...

Injection molding machine maker Engel reports that it will debut a digital process validation tool for medical technology applications at K 2025 in Düsseldorf, Germany. The custom product combines ...

A structured cleaning procedure is essential to ensure the effective cleaning of equipment. Given the fact that pharmaceutical products command a high value, not only financially for the developer but ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...