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
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
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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
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
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
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
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)
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
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
