Compliance

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.

This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.

China is the second biggest economy in the world. The strong economic growth of the last decades has lead the country to develop its own quality standardization system. The China Compulsory Certification (CCC) is a system which is comparable, but not identical in terms of standards and requirements to the EU’s CE mark or the FCC’s declaration of conformity in the U.S.

This month, read our interview with Angela Lambert, Clarion’s head of standards compliance, to...

The market for automotive vehicles is growing rapidly in China, especially the market for passenger vehicles. This article provides an overview of the general regulations and new rules that will come into effect.

Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.

Mexico has published a new standard establishing updated energy efficiency requirements for certain lighting...

Why? Why is it that one of the biggest aggravations in product safety is that of markings? For some reason, it seems that we can never get the markings right the first time. Furthermore, it seems that markings that have been acceptable for years will suddenly go bad.

The question of whether or not to use additional languages on your safety labels can be a complex one to answer.

It’s time for ship authorization and production shipments to begin. But, to everyone’s surprise the system does not have the green light to proceed.