FEATURED RESOURCE
COVID-19 resources, news, and analysis
Visit our new resource center to stay informed about global medical device news related to COVID-19.
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FEATURED SERVICE
New MDD Smart Builder now available
Supports compliance to MDD and prepares for seamless transition to MDR
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Featured Service
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 RESOURCE
New white paper: Residual risk analysis of user interaction problems
Read our newest white paper to learn how residual risk analysis fits into the larger human factors engineering process.
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MDR resource center checklist
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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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

Latest insights on FDA expectations from the 2020 Virtual HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS: FDA recognizes the constraints that COVID-19 has placed...
US FDA to temporarily accept changes to devices approved through PMA or HDE

Normal requirements for regulatory submissions or notification periods will be waived in certain cases impacted...
European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies

European Notified Body designation renewals eased ahead of new MDR date of application

South Korea adds renewal requirement for new medical device authorizations

A revision to the law governing medical devices states that marketing authorizations now last for...

Events

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

Combination products: common use errors and design considerations
Webinar
Human Factors Research & Design
Combination products: common use errors and design considerations

Wed Jun 03

FDA and Medical Device Emergency Use Authorization (EUA)
Webinar
Market Access
FDA and Medical Device Emergency Use Authorization (EUA)

Thu Jun 04

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

Tue Jun 23

News

Get updates about Emergo by UL in the field and in the press. View All

EMERGO by UL teams with Greenlight Guru to provide digital medical device market access

EMERGO by UL has formed a strategic alliance with medical device quality management system software...
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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