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

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RAMS

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

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OPUS

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

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Software

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

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

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TalkingPoints

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

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The demand for combination products continues to grow.

Pharmaceuticals / BioTech

The demand for combination products continues to grow. We partner with combination product developers to overcome regulatory challenges as well as design safer, more effective products that help deliver more personalized and precise care.

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Latest Pharmaceuticals / BioTech news

The latest industry insights from our global team.

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2023 HFES
  • Insights
May 16, 2023

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Part 2 of our report on key human factors engineering themes at the 2023 HFES conference
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  • Insights
May 14, 2023

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

How medical device use and development are affected by differences in healthcare systems and clinical practices in different markets
HFE image 0523
  • Insights
May 14, 2023

Retroactive Interference in Training Decay Periods

How human factors engineering professionals can employ retroactive interference techniques to improve training outcomes
Final rules for combination products, patient reports for medical device evaluation
  • Insights
Apr 19, 2023

Conducting Sharps Injury Prevention Tests

Injury prevention features and testing for injection devices
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HIPAA & GDPR Overview
  • Guide

HIPAA & GDPR Overview

Secure data management to meet HIPAA, GDPR requirements and achieve regulatory compliance.
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  • Process Chart

US FDA Registration Process for Medical and IVD Devices

This process chart illustrates the FDA approval process per device classification in the U.S. and is available for download in the Regulatory Affairs Management Suite (RAMS).
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  • Process Chart

Japanese Regulatory Approval Process for Medical Devices

This process chart illustrates the pathway to market per device classification in Japan and is available for download in the Regulatory Affairs Management Suite (RAMS).
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  • Process Chart

Australian TGA Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the TGA approval process per device classification in Australia and is available for download in the Regulatory Affairs Management Suite (RAMS).
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