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Standards and Compliance

U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...

Update on CCC Certification Scheme for Automotive Parts

Chinese Certification Authorities to Announce Important Changes in the CCC Certification Scheme for Automotive...

A Look at the European Commission’s New Low Voltage Directive Guide

The European Commission's Low Voltage Directory (LVD) legal obligations vary for economic operators, with most falling upon manufacturers. The new LVD Guide offers interpretation and instruction on these obligations, clarifying when importers and distributors might take on manufacturer responsibilities among other issues.

Brexit and Its Impact on Market Access

This article provides an analysis of the steps that manufacturers and distributors can take now to help ensure their continued access to the markets in the 27 remaining European Union Member States (EU-27) following the exit of the United Kingdom on 30 March 2019.

Upcoming Changes to UN 38.3 Lithium Battery Testing

This article provides information on the changes found in Amendment 1 to the 6th Edition of UN 38.3, which details recommended testing to assess potential hazards associated with lithium-ion batteries in transit.
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FDA Proposes Improvements in De Novo Pathway for Medical Devices

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

FDA Issues Final Guidance on Manufacturing Site Changes

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

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.
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