medical devices

A recent paper published in the Journal of Law and the Biosciences maps out how the introduction of artificial intelligence (AI)-based medical devices may challenge current regulatory requirements, including the European Union’s Medical Device Regulation (MDR).

TDK Corporation has expanded its line of power supplies to include additional output voltages aligned with the requirements of medical and industrial systems and devices.

Recognizing the growing deployment and use of AI-enabled technologies, the U.S. Food and Drug Administration has published a white paper on the use of AI in medical products and devices.

The FDA has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.

Integrating a radio into a medical device can have many benefits but also introduces new challenges in compliance. Ensuring coexistence with other radios can be critical to the essential performance of medical equipment.

The FDA has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency.

The U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.