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Standards and Compliance

FDA Issues Final Rule on Medical Device Classifications

The U.S. Food and Drug Administration (FDA) has published a final rule that brings...

The Antenna Measurement Standard IEEE 149 Finally Gets an Update

In its current form, IEEE Std 149 “IEEE Standard Test Procedures for Antennas” is a marginally useful document. While the standard is a good source for interesting and pertinent information, the document has not undergone a significant update since 1979. The changes to the new version of the IEEE Std 149 will make the document an essential reference in any laboratory that conducts antenna measurements.

Protecting Industry from HEMP and IEMI

Protection from high-altitude electromagnetic pulse (HEMP) and intentional electromagnetic interference (IEMI) is an important consideration to the design of modern electronic systems, especially those that control critical infrastructures.

FDA Releases Draft Guidance of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for...

U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...
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The European Commission’s Latest EMC Directive Guidance

The European Commission, the executive body of the European Union, published its latest “Guide for the EMC Directive.”1 Updated to reflect the 2014 recast of the Directive, the Guide discusses various issues, not least what constitutes “inherently benign equipment” and “custom built evaluation kits.” This article reviews the content of the new Guide, highlighting key changes from the previous edition of the Guide published in 2010.

Analyzing Risk Before and After Sale

This article will discuss risk assessment techniques before and after sale and some of the legal and practical implications arising from their use.

FDA Seeks Comment on Class 1 Accessories

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed...

As ANSI Celebrates 100 Years, Standardization Takes A Leading Role in Driving Innovation

This year, the American National Standards Institute (ANSI) celebrates 100 years of leading the collaborative U.S. standardization system.

U.S. FDA Seeking Input on Software Precertification Pilot Program

The U.S. Food and Drug Administration (FDA) is seeking public comment on an updated version of its proposed pilot program to speed the approval of software used in digital health applications.
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