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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May 26, 2023

New Confirmation Letter from European Commission on MDR Extensions

European Commission publishes new letter on Regulation (EU) 2023/607

IVD Expert Panel now accepting submissions for performance evaluation consultations

May 26, 2023

Mexican Regulators Update Rules for IVD Medical Devices

Mexico's Ministry of Health revises classification requirements for in vitro diagnostic devices

May 22, 2023

Mexico Ministry of Health Updates Rules and Requirements for Medical Device Classification

A look at new and updated classification rules under the latest Supplement of Medical Devices of the Mexican Pharmacopoeia

May 17, 2023

Global Impact of (EU) Regulation 2023/607

Based on the glacial progress, delays with regulatory compliance, and paucity of notified bodies, (EU) Regulation 2023/607 was promulgated in mid-March to provide a longer transition timeline for manufacturers with legacy devices in the EU.

Events

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

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Mon May 29, 2023

MDR: Common Issues for Medical Device Manufacturers (Presented in Portuguese)

This presentation, presented in Portuguese, reviews the resources of the European Commission.

Tue Jun 13, 2023

US FDA electronic Submission Template and Resource (eSTAR)

Join our Emergo by UL subject matter expert as they outline the latest updates about US FDA electronic Submission Template and Resource (eSTAR).

Thu Jun 22, 2023

Meeting Global Regulations and Expectations for HFE

Meet the human factors engineering (HFE) expectations, regulations and standards of a global marketplace.

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