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Prepare efficient FDA 510(k) submissions with RAMS
The RAMS 510(k) Builder allows you to create your submission with guided form completion software, collaborate with teammates, and format your document to FDA requirements.
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MDR Gap Assessment and CE Transition Strategy
Europe's new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in mid-2020.
Does it impact you?
FEATURED ARTICLE
More companies apply early-use testing
Manufacturers can use testing to save time, money, and effort during product development
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MDR Resource Center

The knowledge you need for MDR implementation

Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.
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Our Services

Our experienced staff and global network will provide the support you need.

Human Factors Research & Design

Helping clients bring products to market and ensuring best-in-class user experiences.

Market Access

A leading consultancy with more than 2,800 medical device and IVD clients worldwide.

Clinical Research

Emergo's CRO team is 100% focused on clinical research for medical devices.

Digital Health & Cybersecurity

Meet regulator expectations and reduce your risk of cyber threats with early cybersecurity assessments.

Blog

The latest industry news and insights from our global team. View All

UK bill governing medical devices gets reading in House of Commons

The draft legislation offers hints at what the UK's independent regulatory framework might look like.
Human factors terminology breakdown

Key terms for understanding medical device human factors and usability concepts

India update: Expanded scope of medical device regulations, plus new expedited registration route

CDSCO changes to broaden scope of medical device regulatory oversight in India

Challenges for successful medical device clinical monitoring

How clinical trial monitoring can ensure reliable clinical evidence for medical device manufacturers

Events

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

Greenlight Guru True Quality Roadshow in Houston, TX
Workshop
Market Access
MDR Resource Center
Greenlight Guru True Quality Roadshow in Houston, TX

Wed Feb 26

HFES International Symposium on Human Factors and Ergonomics in Health Care
Tradeshow
Human Factors Research and Design
HFES International Symposium on Human Factors and Ergonomics in Health Care

Sun Mar 08

11th Global Drug Delivery and Formulation Summit
Other
MDR Resource Center
Human Factors Research & Design
11th Global Drug Delivery and Formulation Summit

Mon Mar 09

News

Get the latest global medical device regulatory news, insights from our experts, and more. View All

Emergo by UL’s 510(k) Builder for more efficient FDA premarket submissions now live on RAMS software platform

Emergo by UL has launched 510(k) Builder, a new software tool supporting streamlined generation of...
Emergo by UL experts present on human factors engineering in healthcare robotics

Members of the HFR&D team appeared at the inaugural Healthcare Robotics Engineering Forum in Santa...

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