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.

Medical Device Market Access Consulting

Medical Device Market Access

Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997.

Contact us

Regulatory consulting for medical devices and IVDs

Our consulting team has supported our customers with thousands of medical device and IVDs projects.

We help medical device and IVD companies register their products in more than 20 countries, including Australia, Brazil, Europe, Japan and the U.S.
Over 150 consultants globally
Diverse product experience and specialized areas of focus to solve your toughest challenges

Medical device market access services

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Regulatory affairs consulting

Leverage our expertise to solve complex regulatory challenges. We will design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide.

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Device registration

We utilize years of hands-on experience to help our customers get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.

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In-country representation

Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their device registrations.

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Post-market surveillance

We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.

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Software development consulting

Leverage our expertise to help you achieve regulatory compliance and start selling your medical device in global markets.

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Global regulatory M&A services

Our expertise supports regulatory compliance that is seamlessly integrated into your Mergers and acquisitions (M&A) strategy, facilitating smooth transitions and helping to preserve the value of your transactions.

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RAMS®: Regulatory Management Affairs Suite

Introducing RAMS, Regulatory Affairs Management suite, a digital platform for global market access.

Leveraging more than 20 years of regulatory experience, we developed our digital platform to enable regulatory intelligence, research and more.

Find out what RAMs can do for you!

Learn more

Global medical device market access consulting

We have helped our customers expand their reach to major device markets worldwide. View our services by region below.

European Union

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

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United States

From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.

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Japan

Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.

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Brazil

Gain access to one of Latin America's biggest medical device markets with the help of our Brazil-based team.

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Mexico

We provide submission preparation and classification consulting to help companies navigate COFEPRIS requirements.

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Global Services

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

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Looking for EU MDR help?

Visit our MDR Resource Center to meet our MDR team and get free educational resources on the MDR.

Learn more

Medical device market access news

Get the latest industry insights from our Market Access experts.

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European Commission Releases New Management Incident Report Form and Help Text

Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European...

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QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485

The South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System...

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South Korea’s MFDS Revises K-GMP Regulations for Medical Devices and IVDs

South Korea’s Ministry of Food and Drug Safety (MFDS) has revised legislation related to manufacturing and quality...

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Mexico’s COFEPRIS publishes the final version of the GMP Standard

We discuss final updates to NOM-241-SSA1-2025 on Good Manufacturing Practice (GMP), their relevance, and how they...

Events

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

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Tue May 20, 2025

Hospitalar 2025

Schedule a meeting to learn more about how we can support you in getting to market faster.

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Wed May 21, 2025

Open Forum: Usability Testing Q&A

Our senior HFE experts will answer your pre-submitted and live questions on conducting usability testing of medical...

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Wed May 21, 2025

5th Annual European Medical Device Human Factors and Usability Engineering Conference

Heading to the TT 5th Annual European Medical Device Human Factors and Usability Engineering Conference? Don’t miss...

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Tue May 27, 2025

Applying Human Factors in the Course of Post-Market Surveillance

Develop a greater understanding of the importance of incorporating human factors engineering (HFE) into post-market...

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