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The change request was 40 words. Its impact touched six files, the risk file, and a validation protocol.

The email was one paragraph, sent on a Friday afternoon by a supplier I had never spoken to. They were changing the polypropylene resin in the sterile barrier pouch we used for our surgical sets. "Nothing about the device is changing," they wrote. Also true, and also not true. What was actually cha…

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  1. 2026-11-01 16:11 · DEV Community — AI
    The change request was 40 words. Its impact touched six files, the risk file, and a validation protocol.

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