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

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RADAR : Market Access Newsletter

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TalkingPoints : Human Factors Newsletter

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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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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  • Regulatory Update
Sep 13, 2023

US FDA Finalizes 2016 HFE Draft Guidance for Combination Products

FDA released new Q&A-style guidance document finalizing 2016 HFE draft guidance for combination products

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  • Insights
Aug 22, 2023

Knowledge Tasks, Product Labeling Design and FDA Guidelines: Webinar Debrief

An overview of Emergo by UL’s approach to knowledge tasks to align with FDA expectations.

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  • Regulatory Update
Aug 11, 2023

European Competent Authorities Sound Alarm on IVD Shortages

Recent surveys of IVD manufacturers in the European Union show slow transitions to IVDR compliance
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  • Press Release
Aug 11, 2023

Emergo by UL Accredited for Research Tax Credit Programs Promoting Innovation in France

New innovation program provides incentives for French companies to conduct research and development through accredited organizations including Emergo by UL
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  • eLearning Course

Designing Instructions

Learn about designing effective instructions for medical products, including instructions that might take the form of instructions for use, quick reference guides, package inserts, online help and operator manuals.
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  • eLearning Course

Designing a Software User Interface

Learn about a software user interface (UI) design process that is tailored to the development of medical products of various type.
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  • eLearning Course

Applying Human Factors Engineering to Medical Product Development

Learn how to apply human factors engineering to medical products and the HFE process as it is prescribed by regulators and outlined in industry standards.
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  • eLearning Course

Writing User Interface Requirements

Learn how to convert the findings from user research into interface requirements.
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