FDA Compliance
Quality Digest recently spoke with David Isaacson, the executive director of portfolio marketing at Octave. Besides his work on marketing strategies, he also helps people manage, understand, and better control their operations with software solutions that protect industry assets and people while…
Industrial robots don’t just shape pay today. Research from Pinar Yildirim, a Wharton professor of economics and marketing, shows they also make workers less likely to move into higher-paying occupations, cutting expected lifetime earnings.
“Workers aren’t necessarily losing their…
Hospitals continue to face increasing financial uncertainty as healthcare reimbursement rates shift and margins tighten.
Medicare reimbursed hospitals at just 83 cents on the dollar in 2024, driving more than $100 billion in underpayments. At the same time, rising labor, supply,…
Chemical manufacturing employs roughly 500,000 people in the United States. According to the Bureau of Labor Statistics, workers in that sector noted a total recordable incident rate of 4.2 in 2024, compared to the all-industry average of 3.2. That’s a 32% gap, and it has resisted decades of…
A CAPA investigator opens an AI-enabled quality management system and asks for potential root causes. The system produces several plausible explanations, summarizes similar historical events, and recommends corrective actions. The investigator reviews the suggestions, selects one, and closes the…
The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”
That’s the wrong way to read this. If you build medical devices, treating this issue as an AI…