The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The Food and Drug Administration announced that Philips recalled the software following 109 reported injuries and two ...

Quality Management Systems (QMS) are integral for medical device manufacturers as they ensure adherence to regulations and help in producing top-quality products. Utilizing the right QMS software ...

The FDA announced today that a Philips recall involving remote cardiac monitoring software is Class I, its most serious ...

It is not alone, as other health systems discover that reprocessing single-use medical devices can be a win-win for finances ...

When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal ...

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

Korea designates 29 innovative medical devices, prioritizes GMP review for 2025 Korea identifies 29 cutting-edge health ...

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

Eclypsium security researchers have uncovered UEFI vulnerabilities in the Illumina iSeq 100 DNA sequencer, but the broader ...

Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed ...