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Recent Posts
- Your Router Might Be a Spy: FCC Cracks Down on Foreign-Made Devices
- FDA Gives Its Standards List a Tune-Up (Because Even Regulations Need Updates)
- 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
April 2026 M T W T F S S 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Author Archives: Keith Cooper
Your Router Might Be a Spy: FCC Cracks Down on Foreign-Made Devices
In a move that sounds like it came straight out of a cybersecurity thriller, the FCC has decided that your humble home router might be doing more than just streaming Netflix—and it’s not amused. As of March 2026, the agency … Continue reading
Posted in CE marking
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FDA Gives Its Standards List a Tune-Up (Because Even Regulations Need Updates)
The U.S. Food and Drug Administration (FDA) has rolled out its latest refresh of the Recognized Consensus Standards List, and for medical device manufacturers, it’s the regulatory equivalent of a software update—complete with new features, improvements, and a few important … Continue reading
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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
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Proposed Updates to MDR and IVDR for Europe
EU Wants Less Red Tape and More Medical Tech Magic (With Fewer Forms to Fill!) If you thought medical device rules in Europe were complicated… well, you were right. But rejoice, regulatory warriors and folks who get paid to read … Continue reading
Posted in CE marking
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NFPA 790 vs. NFPA 791: A Field Evaluator’s Guide to This Dynamic Duo
If you’ve ever been summoned to inspect an unfamiliar piece of equipment in the field—armed with nothing but a safety vest, questionable optimism, and a clipboard—you’ve probably run into the mysterious pair known as NFPA 790 and NFPA 791. They … Continue reading
Posted in CE marking
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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)
If you’ve ever prepped a medical device for a regulatory review, such as an FDA 510K submission, you’ve probably hit that moment where you ask yourself: “Wait—why do we have to run the EMC tests, called out in IEC 60601-1-2, … Continue reading
Posted in CE marking
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Why ISO/IEC 17025 Accreditation Matters for Electrical Safety & EMC Testing | F2 Labs
Electrical safety and EMC testing might not sound thrilling at first (unless you dream in oscilloscopes), but these tests are what keep your devices safe, compliant, and reliable. The only problem? Those test results only mean something if the lab … Continue reading
Posted in CE marking
Tagged accreditation, CE marking, Electrical Safety, EMC testing, IEC Standards, ISO 17025, Product Compliance
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So You Need to Field Evaluate Your Equipment – What You Need to Know
If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we … Continue reading
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Corrosion | Salt Fog Testing: Like taking your product to the beach
Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at the spa it expected – instead – it’s a nightmare at the beach. That is Corrosion/Salt Fog Testing.. This testing … Continue reading
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