medical devices

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.

The U.S. Food and Drug Administration (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.

This article explores the evolving landscape in the medical industry, focusing on key standards such as IEC 60601-1 and new guidelines implemented to address the next generation of medical devices.

The U.S. Food and Drug Administration (FDA) has published a Final Guidance to clarify...

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its latest reports on the agency’s activities in support of the safety and innovation of medical devices.

In this recent Application Note, SCHURTER emphasizes the importance of compliance with the medical standard DIN EN ISO 13485 to ensure the safety and reliability of medical equipment, specifically as it relates to the development and integration of HMI solutions.

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The FDA has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.