FDA Compliance
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…
Aerospace qualification standards continue to shift as component designs grow more intricate and real-world forces become better understood. Traditional single-axis testing methods don’t capture the complex, multidirectional stresses that modern spacecraft and aircraft encounter. Multi-axis…
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…
Manufacturers have spent millions investing in safer equipment, smarter automation, and increasingly sophisticated operational technology. Yet employee disengagement, one of the most significant risks to workplace safety and productivity, remains stubbornly difficult to address.
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We often think of AI as a technological revolution that will transform industries, disrupt jobs, and change the nature of competitive advantage. But inside organizations, it’s unfolding in a much more complex, less predictable way. In many firms, AI is still more narrative than operational…
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)…