Wearables

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  FDA General Wellness Guidance 2026: How to Prototype an AI Health Wearable Without Becoming a Medical Device

  For founders and product teams building AI-powered fitness, sleep and recovery wearables. What FDA's January 2026 general wellness update changed, where the line to a regulated medical device now sits, and how to build validation, claims and firmware into the first prototype.

  Read more: FDA General Wellness Guidance 2026: How to Prototype an AI Health Wearable Without Becoming a Medical Device
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  Production Tracking: Traceability, Yield and Getting Off Paper Travelers

  Production tracking records what was built, by whom, from which lot and whether it passed. Here is what to capture and which system level fits your line.

  Read more: Production Tracking: Traceability, Yield and Getting Off Paper Travelers

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