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MDR Gap Assessment and CE Transition Strategy
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About Emergo by UL
About Us

We are trusted life and health sciences experts

We specialize in global medical device and IVD compliance and innovation. Emergo connects people to safer, more secure services, experiences and environments.
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Our Services

Our experienced staff and global network will provide the support you need.

Human Factors Research & Design

Helping clients bring products to market and ensuring best-in-class user experiences.

Market Access

A leading consultancy with more than 2,800 medical device and IVD clients worldwide.

Clinical Research

Emergo's CRO team is 100% focused on clinical research for medical devices.

Digital Health & Cybersecurity

Meet regulator expectations and reduce your risk of cyber threats with early cybersecurity assessments.

Blog

The latest industry news and insights from our global team. View All

South Korean MFDS reduces submission requirements for high-risk medical devices

The South Korean Ministry of Food and Drug Safety (MFDS) has moved to reduce registration...
Medica 2019 report: MDR readiness checklist ahead of May 2020 deadline

With the European Medical Devices Regulation (MDR) compliance a dominant topic at the Medica 2019...
Brazil update: ANVISA readies change application system, lists top medical device regulatory priorities

Brazilian regulator planning new system for medical device modification applications

European Commission extends application deadline for MDR, IVDR expert panels to late November 2019

MDR, IVDR Expert Panel applicants now have a deadline of November 24

Events

Learn from our experts through live webinars, workshops, and tradeshows. View All

Medical device registration requirements in China
Webinar
Market Access
Medical device registration requirements in China

Thu Dec 12

News

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

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

Cytotron® qualifies for FDA Breakthrough Devices Program 

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....
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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