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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FEATURED SERVICE
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 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

COVID-19

RESOURCE CENTER

The medical device and IVD industries continue to evolve in response to COVID-19. Find free resources for global regulatory news, emergency use pathways, cybersecurity tips, and more.

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Blog

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

Mexican regulators set aggressive new deadlines for medical device equivalency route approvals

COFEPRIS intends to boost efficiencies of expedited market access routes for qualifying medical devices
EC publishes IVDR classification rules and draft standardization request

The new documents released by the European Commission offer insights into the new system that...
US FDA introduces Certificate for Device Not Exported from the United States (CDNE)

The Agency published eligibility criteria and application guidelines for the certification, which is used for...
Effective CAPA management: Key steps for medical device manufacturers

What does a robust CAPA process for medical device quality assurance and safety look like?

Events

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

Applying Human Factors and Usability Engineering to Medical Devices (GERMAN) - Part II
Webinar
Human Factors Research & Design
Applying Human Factors and Usability Engineering to Medical Devices (GERMAN) - Part II

Thu Dec 03

News

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

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...
EMERGO by UL teams with Greenlight Guru to provide digital medical device market access

EMERGO by UL has formed a strategic alliance with medical device quality management system software...

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