COVID-19 resources, insights, and news 

FEATURED SERVICE
Navigate the post-Brexit regulatory environment
Emergo by UL can provide UK Responsible Person (UKRP) services to allow your company to distribute medical devices, IVDs, or combination products in the United Kingdom.
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Create your IVDR Technical Documentation faster with RAMS
The newest RAMS Smart Builder walks you through the IVDR Technical Documentation File so you can save time and minimize errors that delay regulatory approval.
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FEATURED RESOURCE
Expert resources to plan your EU IVDR transition
The EU IVDR deadline is less than two years away. Visit our IVDR Resource Center for the latest resources, tools, and news from our regulatory and human factors experts.
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Get insights from our human factors experts
Subscribe to TalkingPoints, a monthly round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
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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.

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

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

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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.

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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.

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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

HFE for over-the-counter medical devices and combination products: Nice to have or necessary?

Does your company need to dedicate time and money to human factors engineering (HFE) and/or...
US FDA ramping up permanent 510(k) exemptions for dozens of medical devices

Permanent exemptions from 510(k) requirements proposed for several devices as FDA focuses on COVID-19 public...
TGA carves out exemptions for some software-based medical devices

The listed products, including both physical devices and software as a medical device (SaMD), will...
Chinese regulators announce classification adjustments and UDI submission guidelines

The NMPA made revisions to its medical device classification catalog including the down-classification of 15...

Events

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

Threshold Analyses: Inspecting for User Interface Differences
Webinar
Human Factors Research & Design
Threshold Analyses: Inspecting for User Interface Differences

Thu Jan 28

Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)
Webinar
Market Access
MDR Resource Center
IVDR Resource Center
Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)

Thu Feb 18

News

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

RAMS platform update expands medical device and IVD regulatory toolkits

The newest version of the RAMS SaaS provides new Smart Builder, Regulatory Intelligence and related QA/RA...
Emergo by UL and CMTC (China) to Collaborate on Human Factors Research & Design

Partnership advances human factors engineering and usability of medical devices in China

RAMS 2.5 launches, expanding automated RA/QA capabilities for medical device and IVD companies

RAMS 2.5 offers expanded medical device and IVD market coverage, plus new Smart Builder tools...

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