Author Archives: Keith Cooper

Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”

Posted on August 22, 2025 by Keith Cooper

Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone of medical device compliance. If you’ve ever stared at a test plan wondering, “Do I really need to define this?”—this … Continue reading →

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Adapting to Evolving U.S.-China Regulatory Dynamics

Posted on August 4, 2025 by Keith Cooper

Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts. … Continue reading →

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REACH/RoHS and Continuing Compliance

Posted on July 18, 2025 by Keith Cooper

* Until August 15th, if you mention this blog post we will offer special pricing (20% off) your full REACH and RoHS evaluation with F2 Labs. * We evaluate your device and keep it on autopilot, painlessly. The RoHS Directive 2011/65/EU+(EU)2015/863 started … Continue reading →

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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 →

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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