Standards and Compliance

In a major development for medical device manufacturers, the Parliament and Council of the European...

This article presents the legal issues around pre- and post-sale safety improvements in products and provides recommendations to document them.

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

Understanding the Process to Create Standardized Symbols and How It Effects Your On-product Warnings The...

The standards development and revision process can appear to be a lot like consulting some hallowed oracle with edicts or directives that cannot be questioned.

When it comes to contracts, what terms and conditions are most important, and how can engineers support their company’s efforts to evaluate and minimize risks?

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

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.