Standards and Compliance

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

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

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

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

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

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.

The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE) Program.

Accredited test laboratories, complying with the requirements of ISO/IEC 17025 have to evaluate measurement uncertainty.

Many EMC engineers consider the American National Standards Institute (ANSI) C63® Committee on EMC to be the National Committee on EMC for the United States.