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

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

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

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

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The FDA this week issued a draft guidance with recommendations for submitting medical devices that include AI_enabled ...

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