The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

One could be forgiven for feeling the same way about the current world of drug delivery devices, with an increasingly ...

This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning ...

Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and ...

Yash Siddhartha, Flexan’s President, Medical Device Solutions (MDS), discussed with Med Device Online his vision for the ...

As the world contends with a growing number of extreme weather events and global shipping routes are increasingly impacted by geopolitical strife, supply chain challenges have surged. Thus, ...

More than ever, consumers use audio devices, such as True Wireless Stereo (TWS) earbuds, for voice communications and calling on the move, often in loud public environments. Outdoors and wind noise, ...

The FDA’s final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions (AI-DSFs) has arrived, replacing the draft guidance issued in April 2023. While the ...

The Lee Company’s Smart Pump Module (SPM) combines our piezoelectric disc pumps with drive electronics and pressure sensing in a tightly integrated package. The SPM can be controlled with either UART ...

The issue of misuse of medical devices is a major one. Whether it happens by patients using a device at home without proper training or by surgical staff looking for a faster way to operate a device, ...

Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR ...