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In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I,…
Read articleAn analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management…
Read articleThis article is an excerpt from the cutting room floor. It was in an early draft of my book One Piece of Paper: The Simple Approach to Powerful, Personal Leadership (Jossey-Bass, 2011; order your copy here). It covers how to lead through guidelines rather than leading through rules.
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Read articleI was asked to lead a workshop in the sales order department of a manufacturer that we had helped with process improvement on the factory floor. Those efforts had positively reverberated across the company in the form of fewer late and expedited orders. Still, sales order employees were…
Read articleSometimes the key to getting a lot done is to actually do nothing at all.
I’ve been dreading writing this post. Massive writer’s block. “I have nothing to say,” says the tired little voice in my head (no comments from the peanut gallery).
Normally, I write on Sundays.…
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