Standards
The U.S. Food and Drug Administration scrutiny of AI and machine learning in medical devices is intensifying. Yet most companies still apply failure mode and effects analysis (FMEA) methods designed for deterministic hardware failures. AI failures are probabilistic, context-dependent, and often…
Artificial intelligence (AI) workloads are reshaping the scale, speed, and risk profile of data center construction. As AI adoption accelerates, operators need more physical infrastructure, faster deployment cycles, and greater confidence that critical systems will perform as intended after…
Midtier life sciences companies are spending more than ever on quality and regulatory technology, yet many are paying enterprise prices for capability they never use. The right question isn’t whether to invest in a quality management system (QMS) or regulatory information management (RIM)…
For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the…
ISO has set its focus on revising three key management system standards this year. It started with ISO 14001, which covers environmental management and was published on April 15, 2026. ISO 9001 for quality management will follow in the fall. For ISO 45001, the occupational health and safety…
A line operator in a chemical packaging plant notices a torque inconsistency on a capping head. The deviation is within tolerance on the individual reading, but the operator has seen this pattern before; it usually precedes a run of out-of-spec caps over the next two shifts. He would normally…