Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets. That split is where things go wrong.

ISO 14971 applies to your entire device. If your device contains software, or is software, risk…

High-mix manufacturing has become the norm. Production lines are expected to produce more part variants in smaller batches and at a faster pace than ever before—all while maintaining very high quality.

To keep up, many manufacturers turn to automated quality control (AQC). Robots and 3D scanning systems promise consistency, repeatability, and higher throughput. In theory,…

As we celebrate the United States’ 250th anniversary this year, NIST experts have been working to preserve our nation’s history for the next 250-plus years. Among other historic preservation efforts, NIST engineers and scientists created a bespoke time capsule with artifacts from around the country. As required by law, the time capsule was buried in Philadelphia on July 4, 2026, and should…