Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

Oracle Health has introduced a new three-tier validation framework for medical devices that it says standardizes approaches to validating connectivity, functionality and workflow alignment and will ...

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 ...

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 ...

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

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 ...