FDA Compliance
Many leaderships teams staring down the barrel of organizational transformation face a similar dilemma: How do you take a leap into the unknown when there are no clear data, no well-trodden path to follow, and no assurance of success? What if the change you’re considering is uncharted territory…
Our video producer Chris Smith almost watched the Artemis II launch in person. He drove to Kennedy Space Center with all his fancy gear, along the way got stuck in the snow twice—in Texas, of all places—and then NASA scrubbed the launch and rolled the rocket back for repairs. So Chris drove back…
Corrective and preventive action (CAPA) is the backbone of any quality management system. It’s where problems get solved, risks get reduced, and processes become more robust. Yet in many organizations, CAPA has become little more than a documentation exercise.
Forms get filled.…
Three years ago, I’d never heard the term biomedical equipment technician (BMET). I didn’t know the field of healthcare technology management (HTM) existed. Today, I’m a BMET II responsible for making sure critical medical equipment is available and safe for patient care. It’s incredible to look…
Digital transformation has stopped being a trend and become a condition for competitiveness. In practically every sector, including manufacturing, automotive, food and beverage, healthcare, and logistics, the pace of technological change is redefining what it means to manage quality with…
The era of the unlimited, always-on, general-purpose AI agent is ending. Subscriptions weren’t priced for behavior that never sleeps, and a monthly plan burning thousands of dollars in computation was never going to survive the unit economics.
If you’ve tried to get an AI pilot…