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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

European MDCG weighs in on legacy medical device certification issues and MDR

New guidance on legacy device certification under MDD, AIMDD and MDR in Europe

Guide to improve usability for wearable injector devices

A look at common characteristics of wearable medical devices that can lead to use errors,...
DEKRA becomes first Notified Body designated to European IVDR

First European Notified Body designated to issue CE Marking under IVDR announced

US FDA recommendations to mitigate URGENT/11 medical device cybersecurity vulnerabilities

URGENT/11 medical device cyber vulnerabilities prompt risk mitigation recommendations from US FDA

Events

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

Meet Emergo at MEDICA
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Market Access
Meet Emergo at MEDICA

Mon Nov 18

News

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

RAPS recap: Compliance issues for compiling Clinical Evaluation Reports

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

New RAMS digital medical device RA/QA management system from Emergo by UL now available

Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite...

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