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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.
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More companies apply early-use testing
Manufacturers can use testing to save time, money, and effort during product development
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About Emergo by UL
About Us

We are trusted life and health sciences experts

We specialize in global medical device and IVD compliance and innovation. Emergo connects people to safer, more secure services, experiences and environments.
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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

MDR Watch: Are Regulatory Affairs departments in need of more adequate support?

How senior management can support RA/QA staff meet new clinical data requirements under the European...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

FDA announces three-year transition period to ISO 14971 3rd ed. for medical device and IVD...
India’s CDSCO extends medical device compliance deadlines to 2021

Indian registration deadlines for some medical devices pushed out by one year

US FDA issues updates to classification regulations, hires verification services

The final orders addressed exemptions from premarket notification requirements and down-classification of CES devices.

Events

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

MDR and Human Factors – get ready for transition
Webinar
Human Factors Research & Design
MDR
MDR and Human Factors – get ready for transition

Thu Jan 23

News

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

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...
Shreis Scalene Sciences achieves FDA Breakthrough Device Designation with assistance from Emergo by UL

Cytotron® qualifies for FDA Breakthrough Devices Program 

Emergo by UL in South Korea: Applying human factors engineering to medical device development

Incorporating human factors engineering (HFE) into medical device development is more than a regulatory requirement....

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