Standards and Compliance

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...

The U.S. Food and Drug Administration (FDA) has released the final version of its...

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity...

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