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Standards and Compliance

FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its...

FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity...

FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

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

FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

NIST Releases Cybersecurity Framework 2.0 Draft

The National Institute of Standards and Technology (NIST) has recently published for public comment...
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FDA Updates List of Recognized Standards

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

The Legal Perils of Customer Service

Customer service, before and after sale, is one of the most important functions that must be performed by a manufacturer or product seller. It is also one of the riskiest. Obtaining no information, inadequate information, wrong information, misleading information, or harmful information can make it difficult to evaluate future risk, meet your regulatory obligations, and defend a product liability lawsuit.

FDA Issues Guidance on Qualification of Medical Device Development Tools

The U.S. Food and Drug Administration (FDA) has published its final Guidance on the...

FDA Announces eMDR Enhancements

The U.S. Food and Drug Administration (FDA) has posted a list of pending enhancements...

ANSC C63 Committee on EMC: A 2023 Status Report

This article is intended to cover recent operations of the ANSC C63 Committee, including an announcement of a Chairmanship change and detailed descriptions of the most recently released C63 Standards.
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