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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.
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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

Tips for a successful FDA Human Factors meeting, Part One: Preparing for the meeting

Meetings with the US Federal Drug Administration’s (FDA’s) Human Factors (HF) reviewers often yield helpful...
MDR Second Corrigendum: Grace period for some self-certified Class I medical devices

On December 3rd, 2019 the European Parliament adopted the second corrigendum of the Medical Devices...
Saudi FDA moves to single electronic platform for medical device registrations

New SFDA medical device registration system rolls out

MDR watch: Compliance deadline for upclassified Class I medical devices pushed to 2024?

Proposed changes to European MDR would extend deadlines for some Class I devices to 2024

Events

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

Medical device registration requirements in China
Webinar
Market Access
Medical device registration requirements in China

Thu Dec 12

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

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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