Standards

‘This product isn’t approved to be imported into this market,” says a customs official while reviewing the importation documentation.

Local quality and regulatory teams are quickly brought into the conversation and see that the product’s registration has been valid for several…

For decades, the process industries have relied on layers of protection to prevent hazardous events. When risk reduction requirements were high, safety instrumented systems (SIS), governed by standards such as IEC/ISA 61511, provided a clear framework for design, operation, and life-cycle…

Validating AI software makes most quality teams uneasy.

Their unease is not unjustified. The new Annex 22 provides a framework for AI use, but the guidance remains in draft. Most quality teams still have questions, especially around validation.

Why? Quality teams are…

In the medical device industry, compliance isn’t a pop quiz. The U.S. Food and Drug Administration (FDA) has given you all the answers to the test in the form of a regulation: 21 CFR Part 820. That doesn’t mean it’s easy to ace the test. But you now have all the resources you need to pass.

Wrapped snugly in a custom container, seven carefully chosen materials left Earth on Aug. 24, 2025, traveling at 17,500 mph. Nestled at the top of a Falcon 9 rocket, house dust, freeze-dried human liver, and cholesterol joined four other scientific specimens to travel to the International Space…

Capability maturity model integration (CMMI) is a process improvement framework required by many U.S. government contracts. If you’ve been through a CMMI appraisal in aerospace or federal contracting, you know there’s a typical pattern. Things look great on paper. Then the appraisal date gets…