medical devices

The U.S. Food and Drug Administration (FDA) says it will release within the next...

The U.S. Food and Drug Administration (FDA) has announced the publication of a medical...

The U.S. Food and Drug Administration (FDA) has appointed its first Active Director of...

iPhone maker Apple is cautioning certain users of its iPhone 12 models to be...

The U.S. Food and Drug Administration (FDA) has released its plan for regulating certain...

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union...

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help...

The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical...

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.