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  • Regulatory Update
Apr 14, 2025

South Korea’s Digital Medical Products Act Now Enforced

South Korea’s Ministry of Food and Drug Safety (MFDS) announced that the Digital Medical Products Act entered into...
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  • Insights
Apr 11, 2025

Reflecting on the 2025 HFES Healthcare Symposium

Members from the Emergo by UL HFR&D team attended the 2025 HFES Healthcare Symposium last week in Toronto. Below, we...
Sydney Australia
  • Regulatory Update
Apr 10, 2025

Australian Unique Device Identification (UDI) Framework Now in Effect

Australia’s medical device regulator, the Therapeutic Goods Administration, has announced that its Unique Device...
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  • Regulatory Update
Apr 7, 2025

FDA ESG NextGen Now Open for Test Submissions

The test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) has been opened by the...
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  • Regulatory Update
Apr 3, 2025

District Court Ruling on FDA Final Rule Regarding Laboratory Developed Tests (LDTs)

Medical device manufacturers operating in the United States (U.S.) need to be aware of new rules for obtaining market...
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  • Insights
Apr 2, 2025

First Quarter of 2025: Were There Any Global Medical Device Regulatory Themes?

Our regulatory experts cover major regulatory news that has occurred around the world in the first quarter of 2025.
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  • Insights
Apr 2, 2025

Top 5 Dos and Don’ts - Human Factors Validation Testing of Medical Devices for FDA Market Access

Emergo by UL’s senior research director summarizes key considerations to confirm any human factors (HF) validation...
AI and MI enabled medical devices
  • Regulatory Update
Apr 1, 2025

Risk Categorization Per the European AI Act

Our Emergo by UL experts explain the importance of risk categorization in complying with the European Artificial...
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  • Insights
Mar 27, 2025

Article 16(4) MDR & IVDR Certification: What Medical Device Manufacturers Need to Know

Medical device importers, distributors and others who modify medical devices for sale in the European Union should...
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  • Insights
Mar 27, 2025

What is a Cognitive Walkthrough, and Why are They Beneficial to Medical Device Development?

Emergo by UL Human Factors Specialists share tips on conducting productive cognitive walkthroughs during early device...
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  • Insights
Mar 26, 2025

US FDA Warning Letters: Considerations for LDTs including Timelines

Reviewing relevant U.S. Food and Drug Administration (FDA) warning letters can help manufacturers better understand...
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  • Regulatory Update
Mar 14, 2025

Health Canada Continues to Actively Monitor Supply of Medical Devices

The Canadian medical device regulator Health Canada continues to add and remove devices deemed in short supply.
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