The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

Comprehensive service offerings at every point in the product life cycle.

RAMS

A platform of digital products to improve, simplify and automate RA/QA activities

OPUS

Emergo by UL's new human factors tool - provides training, tools, and resources.

The latest industry news and insights from our global team.

RADAR

Stay informed with the most read RA/QA medical device newsletter.

TalkingPoints

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

Learn from our experts through live events.

Our global consulting team works from 20+ offices on six continents.

MedTech

The medical device regulatory landscape is evolving. We help you bring safer products to markets worldwide and maintain compliance – even if your device is novel or high-risk.

Our expertise

Senior man using blood pressure cuff in his home

Bringing Medical Devices Home

Watch as HFE experts discuss the application of HF engineering to medical devices intended for at-home use.

Medical Device Post-market Surveillance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Human Factors Research & Design

Our human factors research and design experts help put safer, more competitive devices in the hands of patients and healtcare providers. See how we can help at every stage of your product development.

European Commission Announces Appointments to Medical Device, IVD Expert Panels

US FDA Registration Process for Medical Devices and IVDs

South Korea Medical Device Classification

Indian Regulatory Approval Process for Medical and IVD Devices

Medical device and IVD registration in China

China Medical Device Registration and Approval

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