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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

Singapore HSA revises guidance and technical documents

The regulatory body has issued numerous updates relating to software registration and notification changes.
China CMDE publishes guidance on generic medical device names

The regulator clarifies principles employed by the NMPA that affect all medical device registrations in...
Health Canada now allows electronic submissions of medical device clinical trial data

Electronic submissions for some medical device clinical trial information now accepted by Canadian regulator
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.

Events

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

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

Applying usability to medical device design presentation featured at MEDI’NOV Connection 2020
Workshop
Human Factors Research and Design
Applying usability to medical device design presentation featured at MEDI’NOV Connection 2020

Wed Mar 25

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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