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

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

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

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

TalkingPoints

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.

Build Your Team's Human Factors Expertise

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.

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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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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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Jun 7, 2023

Australia’s TGA releases important annual charge deadlines for new financial year

Australia’s Therapeutic Goods Administration (TGA) has announced deadlines and key dates for its latest annual charges.

Jun 2, 2023

Mexico’s Ministry of Health Updates Requirements for Medical Device Registration Renewals and Modification Submissions

Mexico’s Ministry of Health has updated its requirements for medical device registration renewals and modification submissions.

Jun 2, 2023

Mexico’s Ministry of Health Updated Regulation for Software as a Medical Device (Appendix X)

Mexico’s Ministry of Health has updated its regulation for software as a medical device (SaMD), known as Appendix X.

US FDA rolls out notification requirements to protect medical device supply chains

Jun 2, 2023

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Submissions

Mexico’s Ministry of Health has updated its requirements for medical device registration submissions.

Events

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

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There are currently no upcoming events scheduled. Please check back at a later time.

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