The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Resources, scale and authority—the most commonly used vocabulary when people compare startups to enterprises. The real difference is quality discipline. Of course, not all startups neglect QA, and ...

Quality management is a mature practice at state agencies. However, transitioning to paperless and digital delivery of design information exposes a vulnerability in how quality management is ...

Tesla recalled over 2 million cars in 2023 due to Autopilot system defects. The QA’s bad, right? It’s not—there was a deeper issue that was rooted in the lack of a culture of quality rather than in a ...