Standards and Compliance

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...

The latest announcement by Chinese Certification Authority CNCA has a significant impact on many automotive suppliers and car manufacturers. Several products were removed from the list of products that require compulsory product certification. Other products must now obtain a CCC Self-Declaration.

The risks of product liability sometime affect technological developments in hardware and software used to make products. They can stifle innovation and make some advancements seem too risky. How does the law view these products and what can be done to evaluate and reduce these risks.

This article will discuss whether there is a risk to overwarning or if it provides better protection than underwarning And, in light of these risks, what should a manufacturer do?

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...

As part of its effort to evaluate its precertification framework for software with medical...

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...

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

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

The standards reviewed here have been developed to help ensure that ICT circuits will be adequately protected against surges, especially those due to lightning.