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.

European Union

We are experts in European medical device and IVD compliance. We'll help you navigate regulatory changes in the EU.

Contact us

View our EU 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...

Person pulling a test strip out of a machine

Clinical Evaluation Reports (CER) for Medical Devices

Compliance support for Clinical Evaluation Reports (CERs), Revision 4 standards and EU Medical Devices Regulation (MDR...

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...

Two people in an office having a discussion

EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers

We can prepare your team with on-site or remote In Vitro Diagnostic Medical Devices Regulation (EU IVDR) training...

Three nurses surround a computer

EU MDR Classification of Medical Devices

Learn the EU MDR classification of medical devices and deepen your understanding of the European CE marking regulatory...

Cosmetic bottles on a shelf

EU MDR Compliance Consulting for Cosmetic and Aesthetic Products

Learn which cosmetic and aesthetic products fall under EU MDR requirements and how your company should prepare for MDR...

Two scientists collaborate on a tablet in a lab

EU Medical Device Vigilance and Incident Reporting

Learn how we can assist with European medical device vigilance and adverse event reporting, FSCA reports, post-market...

Two people having a discussion in front of a laptop

European Authorized Representative for Medical Device and IVD Companies

European authorized representative (EC REP) for medical device and IVD companies. Official EU Authorized Representative...

Hand holding a UV-C light.

European CE Marking Strategy for Medical Devices

Emergo has a well-established presence in the EU with offices in the UK, Germany, France, and The Netherlands. We have...

Person looking at data on a tablet

European IVD CE Marking Services

ANSWERED ON THIS PAGE: What is the regulatory process for IVDs in Europe? What is the European classification scheme...

Group of people meeting in a conference room

European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Emergo assists medical device manufacturers with post-market clinical follow-up (PMCF) studies, investigations, clinical...

Two people reviewing a document in a conference room

Gap Analysis: EU MDD to MDR for Medical Device CE Marking

Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition...

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.