Industry Focus

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

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Services

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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News

The latest industry news and insights from our global team.

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RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device 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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Resources

Information and tools to advance your business.

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Events

Learn from our experts through live events.

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

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Healthcare Providers

Providers are under pressure to embrace tech-based delivery models that make care more accessible but introduce new risks. Our goal is to make life easier for providers and patients by focusing on the core challenges in the evolving state of care.

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  • Service

India Authorized Agent for Medical Device Companies

Explore how we can support you by becoming your India Authorized agent for your medical devices and IVDs.
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  • Service

Notified Body Support

Maintain your CE marking regardless of Notified Body staff shortages.
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  • Service

Medical Device and IVD Registration and Approval in Hong Kong

Emergo by UL can support you by gaining regulatory approval to sell medical devices and IVDs in the Hong Kong Market. This includes full support with the compilation of the registration dossier and acting as your representative.
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Medical Device and IVD Registration and Approval in Thailand

Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.
Latest healthcare provider news

The latest industry insights from our global team.

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  • Insights
Jul 13, 2023

The Bigger Picture: Serving life science companies

A look at our market access and human factors services in the context of comprehensive UL Solutions support for life science and healthcare companies
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
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  • Insights
Feb 8, 2023

Wiklund's Perspective: Patient Deaths Due to Medical Error

The central role human factors engineers play in efforts to mitigate and reduce medical errors
Related resources

Information and tools to advance your business.

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Vietnam Regulatory Approval Process for Medical and IVD Devices

This chart illustrates the DMEC approval process for medical devices in Vietnam and is available for download in the Regulatory Affairs Management Suite (RAMS).

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  • Process Chart

Thailand Regulatory Approval Process for Medical and IVD Devices

The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS).
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  • White Paper

ISO 10993-1 and Biocompatibility

Learn more on how to conduct a biological evaluation ISO 10993-1.
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  • White Paper

Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation

Learn more about EU In Vitro Diagnostic Medical Device Regulations.
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