Standards and Compliance

Stay informed with standards updates, explore standards insights by topic, understand the importance of product liability, and learn international compliance best practices to ensure your products meet global regulatory requirements effectively.

This article will discuss whether there is a risk to overwarning or if it provides better protection than underwarning And, in light of these risks, what should a manufacturer do?

FDA Issues Draft Guidance on Safety of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...

U.S. FDA Seeks Test Cases for Digital Health Software Precertification

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

FDA Issues Guidance on Medical X-Ray Devices and Conformity with IEC Standards

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

FDA Issues Guidance on Premarket Submission Info on Performance Testing

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to...

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Preventing Liability for Component Part Suppliers and Their OEMs

Assessing the liability between the raw material suppliers, component suppliers, finished product manufacturers, installers, and maintenance personnel is a very difficult legal proposition.

Standards for Information and Communications Technology (ICT) Surge Protectors and Protective Circuits

The standards reviewed here have been developed to help ensure that ICT circuits will be adequately protected against surges, especially those due to lightning.

Antenna Selection for IEC 61000-4-3

With so many different antenna options on the market, it is not always easy to understand what will work best for your application.

U.S. FDA Issues Guidance on Medical Devices Containing Materials of Animal Origin

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

FDA Issues Guidance on Device Exemptions from Pre-Market Notification Requirements

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

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FCC Enforcement Bureau Convenes Regulators to Discuss Emerging Trends