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.

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 ...

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 ...

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 ...

Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require ...

As technology continues to become more sophisticated and ubiquitous, its value isn’t necessarily rooted in the general widespread availability that many people have become accustomed to today. The ...

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 ...

To simplify and enhance medical device connectivity across health systems, Oracle Health has launched the Oracle Health Device Validation Program for the U.S.—establishing a standardized approach to ...