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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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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.
Learn about us


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

European Commission extends application deadline for MDR, IVDR expert panels to late November 2019

MDR, IVDR Expert Panel applicants now have a deadline of November 24

Connected injection devices: Human Factors Challenges

Human factors engineering considerations for developing connected injection medical devices, or CIDs

Value of Human Factors Engineering for ancillary adherence technologies in clinical studies

Benefits of applying HFE validation to medical devices prior to undertaking clinical studies

MDR watch: Two Dutch Notified Bodies now designated under Medical Devices Regulation

Seven Notified Bodies now designated for medical device certification under EU MDR

Events

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

Human factors consideration as it applies to Software as Medical Device (SaMD)
Webinar
Human Factors Research & Design
Human factors consideration as it applies to Software as Medical Device (SaMD)

Thu Nov 14

Meet Emergo at MEDICA
Tradeshow
Market Access
Human Factors Research & Design
Clinical Research
Meet Emergo at MEDICA

Mon Nov 18

News

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

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....
RAPS recap: Compliance issues for compiling Clinical Evaluation Reports

2019 RAPS Convergence conference examined issues such as CER and clinical data management challenges

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