Standards by Topic

This article discusses and contextualizes the EU Conflict Minerals Regulation for the electronics sector. While electrical equipment manufacturers that place products on the EU market are not specifically targeted under the Regulation, the law applies to them if their operations involve importing conflict-implicated metals and minerals into the EU (e.g., for use in manufacturing their products). Regardless, the Regulation raises implications for any electrical equipment manufacturer that distributes and sells products in the EU, specifically when it comes to publicly reporting on uses of conflict minerals. The EU’s proposed “transparency platform” is detailed in this regard.

Standards play a critical role in enabling new technologies to go mainstream faster while freeing customers to choose best-of-breed solutions from multiple vendors. Here’s what vendors need to know about why and how to participate in standards-related processes, including conformity assessment activities.

The use of robots and robotics is becoming more common across many industries. As these devices become more common and their use grows, manufacturers must understand the hazards they present, regulatory requirements, and testing options.

The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical...

Is your test software the goose that has laid its golden eggs or is your software misbehaving? Does it run amok? The purpose of this article is to provide an understanding of the software validation requirements, the validation rationale, and suggest independent tools that will allow you to develop your own test software validation process.

This article explains the development process of a proficiency testing programme that is suitable for electrical and mechanical safety tests. The process for testing the homogeneity and stability of specimens is also discussed.

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

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

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