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.
Learn more
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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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

ANVISA extends Brazilian Good Manufacturing Practice requirements to more medical device manufacturers

More medical device and SaMD manufacturing units now subject to BGMP certification rules

IVDR watch: New guidance from European MDCG ahead of date of application

Four new guidance documents from European regulators as IVDR comes into effect

IVDR Watch: European regulators add ISO 14971 to harmonized standards list

Risk management standard EN ISO 14791:2019 added to IVDR reference list.

Brazil's ANVISA repeals medical device regulations related to the coronavirus pandemic

RDC 702/2022 repeals special pandemic-related resolutions.

Events

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

Applying HFE expertise early in the medical product development process
Webinar
Human Factors Research & Design
Applying HFE expertise early in the medical product development process

Wed Jun 01

Clinical data and post-market compliance under the MDR
Webinar
MDR Resource Center
Clinical data and post-market compliance under the MDR

Thu Jun 30

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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