medical devices

Keep your iPhone 12 Away from Medical Devices, Apple Says

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

FDA Sets Action Plan to Regulate AI in Medical Devices

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

EU Commission Opens Options for Remote Audits for Medical Devices

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

FDA Launches Its Safer Technologies Program for Medical Devices

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

FDA Releases Guidance on EMC of Medical Devices

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

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IMDRF Proposes Update on Post-Market Medical Device Studies

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

The IEC 60601 Amendment Updates Have Published: Changes and Impacts

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.