Author Archives: Keith Cooper

FDA Enforcement Flags Data Integrity Risks at Overseas Labs

Posted on June 6, 2025 by Keith Cooper

The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket … Continue reading →

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Cybersecurity and the new Radio Equipment Directive

Posted on May 28, 2025 by Keith Cooper

So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business. Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices Starting August 1, 2025, the EU is tightening the screws on anything … Continue reading →

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Taming the EMC Beast: A Guide to Pre-Compliance Testing

Posted on April 7, 2025 by Keith Cooper

Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials … Continue reading →

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So You Need a Field Evaluation?

Posted on March 26, 2025 by Keith Cooper

So, you’ve just had the pleasure of hearing from an Authority Having Jurisdiction (AHJ) or an electrical inspector, and their message was something along the lines of: “You’ve failed your inspection!” or “Your equipment needs a ‘UL or CSA Certification!’” … Continue reading →

Posted in CE marking, Field Label, SPE-1000, US Field Label | Comments Off on So You Need a Field Evaluation?

The Wacky World of Exempted Devices: What You Don’t Need to Worry About

Posted on March 4, 2025 by Keith Cooper

Ever wonder what kind of electronic devices the government just lets off the hook? No, it’s not your phone, though that would be nice, right? The Federal Communications Commission (FCC) has a special list of devices that don’t need to … Continue reading →

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Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity

Posted on February 7, 2025 by Keith Cooper

Buckle up, folks—our favorite regulatory sheriffs at the FDA have dropped another massive rulebook, this time titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” If you’re still awake after reading that title, congratulations! This document is … Continue reading →

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CE Marking: Your Electronic Product’s Passport to Europe

Posted on February 5, 2025 by Keith Cooper

If electrical products had passports, the CE mark would be their golden ticket to travel freely across Europe. But unlike that dusty old passport you forgot to renew, CE marking isn’t just a stamp—it’s a declaration of compliance with essential … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on CE Marking: Your Electronic Product’s Passport to Europe

Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

Posted on September 30, 2024 by Keith Cooper

Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading →

Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745 | Comments Off on Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

What is an NRTL Field Label and What do I Need to Know About Them?

Posted on September 12, 2024 by Keith Cooper

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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The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know

Posted on August 23, 2024 by Keith Cooper

The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading →

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