medical devices

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...

As part of its effort to evaluate its precertification framework for software with medical...

Design engineers integrate force sensors into medical devices to create smart tools that produce quantifiable data.

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...