Compliance

New harmonized EU cybersecurity standards EN 18031-X took effect August 2025, requiring radio equipment manufacturers to conduct risk assessments across three overlapping standards. Despite similar requirement codes, critical differences in text and restrictions can impact compliance strategies.

Legal problems arise as a result of most recalls. These can take the form of regulatory problems, product liability lawsuits, retailer problems, and damage to a company’s brand reputation. Well before undertaking a recall, product sellers need to consider what problems might occur and what they need to do to minimize them.

This article will illustrate why it is necessary to introduce the control-oriented model to hazard-based safety engineering (HBSE), based on a typical large core switching fan-tray architecture design and related failure model. The authors also provide detailed design and evaluation guidelines, which can ensure the control of random hardware failure and avoid systematic failure (both hardware and software), then achieve the safety target (i.e., safety integrity level).

Change is the only constant. A product lifecycle approach underpinned by a proactive and reactive regulatory and compliance strategy is key to success. Using digital tools to augment that process generates faster yet reliable data and results to bring safer medical devices to market that improve patient outcomes.

Read a quick guide to understanding the considerations of the main label and symbol format options available to you, including pros and cons, and whether they meet the U.S. ANSI Z535.4 standards, the international ISO 3864-2 standards, or both standards.

While the selection of components in electrical equipment plays a crucial role, a sound understanding of the characteristics of safety-critical and high-integrity components can provide valuable information about the ways to advance and achieve safety goals.

Product regulatory compliance is a formal discipline that addresses every aspect of the product lifecycle, helping to ensure global acceptance of new and innovative technologies that are environmentally sound and safe to use.

While the selection of components in electrical equipment plays a crucial role, a sound understanding of the characteristics of safety-critical and high-integrity components can provide valuable information about the ways to advance and achieve the safety goals.

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.

The safety hierarchy is a flexible concept that can be helpful in deciding on a final product design. But it can also be a trap for the unwary design engineer. This article will discuss the safety hierarchy concept, how do you comply with its requirements, and what are the problems associated with it?