Compliance

The U.S. Federal Communications Commission (FCC) adopted new rules to streamline the equipment authorization process that went into effect in late 2018. This article discusses the key changes in detail and provides guidance to those seeking FCC authorization.

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

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

This article describes the latest developments with CISPR Subcommittee B. It highlights the changes in Amendment 2 of CISPR 11 – Edition 6.0 released in January of 2019.

The elements of a program to deal with pre-sale and post-sale safety issues are well-known. But the specifics of what elements should be used and how by a particular manufacturer are often unknown. Therefore, the most important question that must be answered by any company manufacturing finished products or component parts is “What should my company do and how should I do it?”

The evolution of E and H fields on aircraft struck by lightning is a complex process. An October 2014 in-flight lightning strike is reviewed in this article as an example that inspires a fresh look at how lightning E and H fields should be considered for indirect effects certification.

It is a common misconception that any product that complies with IEC 60950-1 will also comply with IEC 62368-1. A key goal of this article is to help readers of IEC 62368-1 understand the underlying safety concerns that the new requirements are trying to address.

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.