medical devices

UCLA researchers are making strides to create a smart patch capable of delivering insulin to patients directly through their skin.

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards...

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of...

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

This article discusses where we are currently with the IEC 60601 series of standards and where we are headed for the next round of amendments (2020 - 2022). Further down the line is the development of the next full edition of the IEC 60601 Series (targeting around 2024 publication).

The U.S. Federal Communications Commission (FCC) has granted a request from a medical device...

In an effort to keep pace with its oversight of advanced medical devices and...

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...