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

Emergo Bundles

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

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 Bundles

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.

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

News

The latest industry news and insights from our global team.

View all

Jan 11, 2022

US FDA Lays Out Post-COVID EUA Transition Plans for Medical Devices

US FDA publishes new guidance on timelines and related requirements for emergency use authorization (EUA) terminations for medical devices and IVDs following COVID-19 emergency resolution. Learn more at Emergo by UL.

Placing medical devices on the Swiss market after the EU MDR Date of Application

Dec 30, 2021

Medical Device Direct Imports to Users in Switzerland

Swiss regulators develop importation plan for medical devices

Dec 17, 2021

Annex XIV of the European MDR and Clinical Development Plans for Medical Devices

The European medical devices regulation (MDR) requires manufacturers to establish clinical development plans (CDP). Learn more about EU MDR requirements at Emergo by UL.

Proposed US FDA program targets medical device supply chain shortages

Dec 14, 2021

US FDA Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices

US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.

Events

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

View all

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

You are leaving the Emergo by UL website for an external site. Emergo by UL structures this activity to be distinct and separate from its conformity assessment bodies.