Standards
Speaking with experts who love their jobs usually makes you aware of two things simultaneously: 1) how much you don’t know, and 2) how much you’d like to know. My conversations with Prashant Darisi and Vick Vaishnavi were no exception. I walked away with an appreciation for the decades of…
With ISO 9001:2026 just around the corner, the topic of internal auditing is likely on the minds of many quality professionals.
This is the perfect time to reexamine your resources and strategies for internal auditing. The single biggest success factor of your audit program is who…
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…