Standards and Compliance

Mexico’s regulatory compliance process can be challenging due to continuous changes in NOM and other requirements. By better understanding the key players and documents that make up the regulatory system, manufacturers can more easily and successfully navigate compliance for radio and telecommunications devices in Mexico.

Each new version of Wi-Fi standards offers more capabilities but also more complicated regulatory testing requirements. Deciding which capabilities to include and planning for pre-compliance testing can save multiple trips to the test labs and reduce time to market.

This article explores the evolving landscape in the medical industry, focusing on key standards such as IEC 60601-1 and new guidelines implemented to address the next generation of medical devices.

Functional safety encompasses various standards and requirements for ensuring safe product operation. Functional safety evaluations are necessary whenever controls are employed to ensure safe product operation, with the process generally similar across projects despite differing nuances in standards and applications.

Manufacturers, retailers, and regulators have been working to improve product safety and make recalls more effective. This has been especially important for online retailers who have additional ways to directly contact their customers.

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has extended...

A consortium of medical technology companies in the European Union (EU) has published a...

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket...