medical devices

The International Electrotechnical Commission (IEC) has released IEC 80601-2-59:2017

As part of its effort to streamline the approval process for high-risk medical devices,...

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

The U.S. Food and Drug Administration (FDA) has published an updated list of consensus...

The China Food and Drug Administration (CFDA) is reportedly considering a new regulation that...

The U.S. Food and Drug Administration (FDA) has announced its intention to revisit its...

Global healthcare company Novo Nordisk has initiated a recall of certain insulin cartridge holders...

The U.S. Food and Drug Administration (FDA) has extended the deadline for certain low-risk...

This article focuses on global wireless compliance. More specifically, it explains what to consider if you intend to certify your device with an integrated third-party module internationally.

A new type of pacemaker runs without wires or a battery, and is completely changing medical technology.