Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be ...

In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software ...

Where is the best place to locate manufacturing to minimize supply chain risk, maintain a low cost of goods sold, and ...

Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of ...

FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 ...

To gain U.S. Food and Drug Administration (FDA) approval and be first to market in the United States, a startup with a novel Class III mitral valve repair therapy needed to first fine-tune some of the ...

To replace a tedious and expensive legacy process, a globally recognized leader in cardiac pacing solutions developed a unique solution to stabilization involving the use of a thin wall thermoplastic ...

A large global medical device manufacturer invented a new textile structure to improve the performance of one of their orthopedic devices. One of the critical parameters identified for the component ...

While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances ...