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.

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

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.

Person holding globe overhead

Global Services

We can help you design and execute a regulatory strategy across major and emerging medical device markets.

Contact us

View our global Market Access services

We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

A freighter at dusk

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries...

Group of business professionals meeting in a conference room

Due Diligence Services for Mergers and Acquisitions

Our due diligence services help medical device companies navigate complex regulatory requirements to avoid...

Surgeons surrounding a patient

Global Registration Consulting for Medical Devices and IVDs

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in...

Doctor pointing to a blue cross on a high tech screen

ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ANSWERED ON THIS PAGE: Why do we need ISO 13485 certification? How will ISO 13485 certification benefit our...

People sitting in a room with a doctor

ISO 13485:2016 Consulting and Gap Analysis

ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout...

Meeting in front of a large information device about universal detection of genes in a specific biological sample.

ISO 13845 Audit and Training Services for Medical Device Companies

We assist medical device manufacturers with on-site ISO 13845 compliance audits, training services, and eQMS support to...

Dominos standing on a table with a hand in between two of the dominos

ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE: What does ISO 14971 require? How do I implement ISO 14971? How do I apply the risk...

Image Of Medical Ventilator. Hospital Respiratory Ventilation. Patient Life Saving Machine

ISO 14971 Risk Management Training for Medical Device Companies

Get trained on medical device risk management and QMS requirements with our fixed fee ISO 14971 course, including group...

Business person sitting at a conference table with two medical professionals

Local Authorized Representative for Medical Device Manufacturers

Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD...

Business professionals shaking hands

M&A Regulatory Due Diligence Services for Medical Devices

Our expertise supports regulatory compliance that is seamlessly integrated into your M&A strategy, facilitating smooth...

Photo of flags from around the world flying in the wind

Medical Device Regulatory Pathway Support for Smaller International Markets

From Algeria to Zambia, we provide custom Regulatory Pathway Reports for almost every country in the world, including...

Person taking notes on a clipboard while someone tests a medical device

Obtaining a Medical Device CFG (Certificate to Foreign Government) from FDA

Emergo can help you obtain a CFG (Certificate to Foreign Government) so that you can show proof of FDA compliance in...

X

Request information from our specialists

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.

Please wait…

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.