COVID-19 resources, insights, and news 

FEATURED SERVICE
Build your team’s Human Factors expertise
Optimal Product Usability Suite (OPUS ™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.
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FEATURED SERVICE
Updated RAMS features offer EU IVDR support
Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits.
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FEATURED SOLUTION
Bundled Options: Emergo Pro and Emergo Pro Plus
RAMS premium options Emergo Pro and Emergo Pro Plus offer flexible solutions to help get medical and in vitro diagnostic devices to market locally or globally.
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Our Services

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

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.

 

MDR

RESOURCE CENTER

Europe's Medical Devices Regulation (MDR) goes into effect in May 2021, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.

START GETTING READY

IVDR

RESOURCE CENTER

Europe’s In Vitro Diagnostic Devices Regulation (IVDR) will bring big changes in May 2022, so it is imperative that you start getting ready. Meet our IVDR experts and find related news and resources.

START GETTING READY

LATIN AMERICA

RESOURCE CENTER

Explore the medical device and IVD regulatory systems of Brazil and Mexico, and access growing markets throughout the region. Find out how we can help you expand your global footprint.

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Blog

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

FDA asks COVID test makers to switch from emergency to premarket approvals

COVID-19 test manufacturers should become familiar with the new rules

Singapore’s HSA to commence Phase I implementation of UDI labeling in November 2022

Sales of some Class D devices must comply by November 1

UK regulator MHRA to raise medical device registration and other fees by 10% or more

Medical device makers may comment until November 23, 2022

Wiklund's Perspective: Automation is (mostly) a good thing

Pros and cons of automation, including for medical devices and technologies

Events

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

Scaling and Conducting Use-Related Risk Analysis (URRA)
Webinar
Human Factors Research & Design
Scaling and Conducting Use-Related Risk Analysis (URRA)

Wed Oct 05

Software as a Medical Device (SaMD): EU/US Regulatory Considerations
Webinar
Market Access
Medical Device Registration
Software as a Medical Device (SaMD): EU/US Regulatory Considerations

Thu Oct 27

News

Get updates about Emergo by UL in the field and in the press. View All

Emergo by UL Launches Digital Human Factors Engineering Platform for Medical Device Manufacturers

The new SaaS offering supports the development of safe and effective medical products and technologies.

Have questions on what Emergo can do for you?

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