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FDA2026年5月19日·2 分钟阅读英文
FDA Regulations on Medical Devices Tighten, Emphasis on Long-Term Control
On February 2, 2026, the FDA's new QMSR replaces QSIT and incorporates ISO 13485 — tightening expectations across the full device lifecycle, including cybersecurity.
阅读全文ESPR2026年5月18日·4 分钟阅读英文
Hardware Regulation Is Moving Toward Cleaner, Traceable Products in 2026: Here's What You Should Expect
Europe's regulatory bodies are pushing manufacturers to prove their products are durable, repairable, recyclable, and traceable. Here's what hardware teams need to know for 2026.
阅读全文FCC2026年5月2日·4 分钟阅读英文
The FCC Just Voted to Remove China From U.S. Electronics Testing: Here's What That Actually Means
On April 30, 2026, the FCC voted to move toward banning all China/Hong Kong labs from testing U.S.-bound radio devices. Here's what it means for hardware teams.
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