COVID-19 resources, insights, and news 

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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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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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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.

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.

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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

In brief: China NMPA seeks feedback on optimization of medical device standards

China’s National Medical Products Administration (NMPA) has started a public consultation on its evaluation of...
New guidelines published on integrating UDI into quality management systems under MDR, IVDR in Europe

European regulators issue recommendations for integrating UDI into medical device, IVD QMS processes

Singapore HSA holds consultation on SaMD classification draft guidance

The Health Sciences Authority (HSA) is inviting stakeholders to comment on its guidelines for the...
US FDA guidelines for remote inspections of drug facilities: Implications for life sciences companies

Remote FDA inspections of drug facilities affecting life sciences companies' learning management and training needs

Events

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

Countdown to IVDR Date of Application – Key Requirements and Challenges
Webinar
Market Access
IVDR Resource Center
Countdown to IVDR Date of Application – Key Requirements and Challenges

Thu Aug 26

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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