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Industry Focus

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

Overview

We have deep expertise with a range of product types, including combination and borderline products.

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Services

Comprehensive service offerings at every point in the product life cycle.

Overview
RAMS

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

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OPUS

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

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Software

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

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News

The latest industry news and insights from our global team.

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Newsletters

RADAR

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

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TalkingPoints

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

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Resources

Information and tools to advance your business.

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Events

Learn from our experts through live events.

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About

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

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Emergo by UL

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.

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.
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FEATURED SOLUTION
Bundled Options: Emergo Pro and Emergo Pro Plus
RAMS premium options Emergo Pro and Emergo Pro Plus offer flexible solutions to help get medical and in vitro diagnostic devices to market.
Learn more
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.
Learn more
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 SOLUTION
Bundled Options: Emergo Pro and Emergo Pro Plus
RAMS premium options Emergo Pro and Emergo Pro Plus offer flexible solutions to help get medical and in vitro diagnostic devices to market.
Learn more

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.

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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.

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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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News

The latest industry news and insights from our global team.

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US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Regulatory Update
Dec 6, 2022

FDA asks COVID test makers to switch from emergency to premarket approvals

The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.
US FDA medical device user fees see modest increase for 2022
  • Regulatory Update
Dec 6, 2022

FDA launches TAP Pilot to speed access to safe and innovative medical devices

The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.
View of London
  • Regulatory Update
Dec 6, 2022

UK regulator MHRA to raise medical device registration and other fees by 10% or more

The UK’s MHRA invited public comment regarding its proposed fee increases.
US FDA formally proposes aligning Quality System Regulations with ISO 13485
  • Regulatory Update
Dec 6, 2022

US FDA issues roadmap to medical device regulatory guidance topics list for 2023

The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.

Events

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

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Wed Dec 14
  • Upcoming Webinars

Medical Device Regulatory Requirements - New Japanese Guidelines

In this complimentary webinar, we will review the resources you’ll require and the steps you should take to complete your path to market in Japan.