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Recent Posts
- EMC Testing for FDA 510(k): Common Mistakes That Delay Clearance
- Wellness Meets Regulation (But With a Smile): An Industry Insider’s Take on FDA General Wellness Policy
- Proposed Updates to MDR and IVDR for Europe
- NFPA 790 vs. NFPA 791: A Field Evaluator’s Guide to This Dynamic Duo
- Why Does EMC Testing of a Medical Device to IEC 60601-1-2, AIM 7351731, and/or Common EM Emitters Testing Have to be Conducted in Both Charging and Battery Modes? (Even When the Device Is Basically Just Napping on the Charger)
Monthly Archives: February 2026
EMC Testing for FDA 510(k): Common Mistakes That Delay Clearance
Every medical device team reaches the same moment: EMC testing is complete, the report looks good, and it feels like time to submit. Then the 510(k) questions begin. Not catastrophic failures — just clarification requests, additional documentation, and timeline extensions. … Continue reading
Posted in CE marking
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Wellness Meets Regulation (But With a Smile): An Industry Insider’s Take on FDA General Wellness Policy
Every wellness startup eventually asks the same nervous question: “Are we about to become an FDA-regulated medical device… or can we keep building?” If you’ve ever had that thought while staring at a fitness tracker, sleep aid, or massage device, … Continue reading
Posted in CE marking
Comments Off on Wellness Meets Regulation (But With a Smile): An Industry Insider’s Take on FDA General Wellness Policy