The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

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RAMS

A platform of digital products to improve, simplify and automate RA/QA activities

OPUS

Emergo by UL's new human factors tool - provides training, tools, and resources.

The latest industry news and insights from our global team.

RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device newsletter.

TalkingPoints : Human Factors Newsletter

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

Learn from our experts through live events.

Our global consulting team works from 20+ offices on six continents.

We Specialize in Global Medical Device and IVD Compliance and Innovation

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success.

New: Human Factors Tools

Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.

Learn more

Updated RAMS Features

Updated features offer EU IVDR Support

Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits

Learn more

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Emergo Newsletters

Get the latest global medical device regulatory news, insights from our experts, and more from the RADAR and TalkingPoints newsletters.

New: Human Factors Tools

Optimal Product Usability Suite (OPUS™ ) – Emergo by UL’s new human factors tools – provides training, tools, and resources.

Learn more

Updated RAMS Features

Updated features offer EU IVDR Support

Discover the new PEP and PER Smart Builders, and utilize the Product Classification service for IVDR kits

Learn more

Emergo Newsletters

Get the latest global medical device regulatory news, insights from our experts, and more from the RADAR and TalkingPoints newsletters.

MDR

RESOURCE CENTER

Europe's Medical Devices Regulation (MDR) went into force in May 2021, requiring action. Meet our MDR team and get complimentary educational resources on the MDR to help you comply with this new regulation.

Learn more

IVDR

RESOURCE CENTER

Europe’s In Vitro Diagnostic Devices Regulation (IVDR) brings big changes, so it is imperative to prepare yourself. Meet our IVDR experts and find related news and resources.

Learn more

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.

Learn more

ASIA

RESOURCE CENTER

The nations of Asia can be profitable targets for medical devices and in-vitro diagnostic device manufacturers hoping to expand their commercial reach. Navigate each market in Asia confidently with Emergo by UL’s global regulatory affairs expertise and local support.

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News

The latest industry news and insights from our global team.

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Man trying an at-home blood pressure device

Sep 21, 2023

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

Human factors specialists might opt to conduct an “out of the box” usability test of a medical device, such as for a home-use blood pressure monitor. In any case, it’s a great way to assess the user experience from the very start of product interactions.

Sep 21, 2023

UI Design Trends for Healthcare and Medical Apps

Good user interface (UI) design ensures that users have a valuable and enjoyable experience when interacting with an application. For mobile apps related to healthcare, a UI that prioritizes the user is of utmost importance as these applications are developed with the goal of improving patients’ lives and the level of care they receive.

Sep 21, 2023

Webinar Debrief: Discovery and Design Methods for User-Centered Product Development

On August 24, 2023, our Human Factors (HF) team’s Cory Costantino and Julee Henry delivered a webinar about how to approach early research, discovery and design during new product development efforts to build a strong user-centered foundation.

multiple analysts conducting a usability study

Sep 20, 2023

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Overcome challenges associated with conducting human factors usability tests with multiple analysts by practicing effective notetaking and data collection.

Events

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

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Two business colleagues collaborating while one writes on a whiteboard

Tue Sep 26, 2023

EU MDR PMS Including PMCF and Vigilance

In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about EU MDR PMS, including PMCF and vigilance.

People shaking hands at a business event

Tue Oct 3, 2023

RAPS 2023

Learn more about Emergo by UL services and software solutions at RAPS 2023.

Thu Oct 5, 2023

Actionable Tips for Leading Usability Test Sessions

Uncover usability insights and design opportunities by eliciting valuable feedback from usability test participants.

Wed Oct 11, 2023

Overview of Japan IVD Registration

In this complimentary webinar, our Emergo by UL expert will outline the latest insights into Japan IVD registration.

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We Specialize in Global Medical Device and IVD Compliance and Innovation

MDR

RESOURCE CENTER

IVDR

RESOURCE CENTER

LATIN AMERICA

RESOURCE CENTER

ASIA

RESOURCE CENTER

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

UI Design Trends for Healthcare and Medical Apps

Webinar Debrief: Discovery and Design Methods for User-Centered Product Development

Conducting Usability Tests with Multiple Analysts | Emergo by UL

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EU MDR PMS Including PMCF and Vigilance

RAPS 2023

Actionable Tips for Leading Usability Test Sessions

Overview of Japan IVD Registration