- Essays··8 min read
When the Inspector Asks Why
The FDA's new medical device inspection protocol went live on 2 February 2026. The Quality Management System Regulation (QMSR) replaced the decades-old Quality System Regulation and incorporated ISO 13485:2016. The agency promised new guidance. It arrived on 30 January 2026, just three days before the QMSR became effective.
wheninspectoraskswhyRead - Essays··8 min read
The Productivity Mirage: Why 19% of AI Users Save No Time
Gartner surveyed employees in Q1 2026 and found that 19% reported no time saved with AI, while their employers went on tracking 'hours saved' as the primary success metric.
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