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Get the latest global medical device regulatory news, insights from our experts, and more.

Feb 3, 2020

Emergo by UL’s 510(k) Builder for more efficient FDA premarket submissions now live on RAMS software platform

Emergo by UL has launched 510(k) Builder, a new software tool supporting streamlined generation of...
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Jan 2, 2020

Emergo by UL experts present on human factors engineering in healthcare robotics

Members of the HFR&D team appeared at the inaugural Healthcare Robotics Engineering Forum in Santa Clara, California.
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Nov 7, 2019

Shreis Scalene Sciences achieves FDA Breakthrough Device Designation with assistance from Emergo by UL

Cytotron® qualifies for FDA Breakthrough Devices Program
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Nov 4, 2019

Emergo by UL in South Korea: Applying human factors engineering to medical device development

Incorporating human factors engineering (HFE) into medical device development is more than a regulatory requirement...
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Sep 24, 2019

RAPS recap: Compliance issues for compiling Clinical Evaluation Reports

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges
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Sep 23, 2019

New RAMS digital medical device RA/QA management system from Emergo by UL now available

Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite...
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Jun 26, 2019

South Korean trade group KMDICA teams with Emergo by UL for medical device RA/QA support

The Korea Medical Devices Industrial Cooperative Association (KMDICA), a South Korean medical device industry association,...
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