Standards and Compliance

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of...

The Commission of the European Union (EU) has recently detailed the criteria and tasks...

Speed and determinism in design, made possible by time-sensitive networking (TSN) technology, is prompting the development of new TSN profiles for a multitude of applications across industry sectors. The IEEE 802.1™ Working Group of the IEEE Standards Association (IEEE SA) offers numerous TSN profiles for applications, including the automotive, manufacturing, and aviation industries.

On the 15th anniversary of his career in international product approvals, the author looks back on what has changed and what has remained the same in the global product approval process.

Recalls are a major contributor to product liability incidents and lawsuits, interactions with government safety agencies, disputes with suppliers and product sellers, and negative publicity with the buying public. New guides have recently been issued that can help a manufacturer and product seller to better understand how to prepare for and implement an effective recall.

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...

The Commission of the European Union (EU) has updated its list of harmonized standards...

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

Safety management programs are necessary to help a company make safe products and monitor safety for products in use. The CPSC has provided lots of guidances and mandates over the years on what constitutes an adequate program. These guidances are potentially useful to those companies seeking to establish a CPSC-compliant safety program and should be considered as part of the program development process.