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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

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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Resources

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

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The medical device regulatory landscape is evolving.

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.

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Our expertise
New Brazil INMETRO ordinance eases inspection and documentation requirements
  • Service

ANVISA Medical Device and IVD Registration and Approval in Brazil

Emergo can assist you in gaining Brazil's ANVISA regulatory approval to sell medical devices on the Brazilian market.
Emergo by UL MDR Resource Center
  • Service

Health Canada Medical Device License (MDL) and MDEL Registration

Learn more about Health Canada regulatory compliance and Emergo by UL's consulting services for Health Canada Medical Device Establishment License (MDEL) and Medical Device License (MDL) registration and approvals.
Latest MedTech news

The latest industry insights from our global team.

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Person doing an audit.
  • Regulatory Update
Jun 9, 2023

US FDA Looking Into Medical Device Registrants’ UDI, GUDID Compliance

US regulator targets possible discrepancies regarding Unique Device identification requirements
Melbourne Australia
  • Regulatory Update
Jun 7, 2023

Australian TGA Releases Important Annual Charge Deadlines

Australia’s Therapeutic Goods Administration (TGA) has announced deadlines and key dates for its latest annual charges.
Basilica Guadalupe Mexico City skyline
  • Regulatory Update
Jun 2, 2023

Mexico’s Ministry of Health Updated Regulation for Software as a Medical Device (Appendix X)

Mexico’s Ministry of Health has updated its regulation for software as a medical device (SaMD), known as Appendix X.
US FDA rolls out notification requirements to protect medical device supply chains
  • Regulatory Update
Jun 2, 2023

Mexico’s Ministry of Health Updated Requirements for Medical Device Registration Submissions

Mexico’s Ministry of Health has updated its requirements for medical device registration submissions.
Related resources

Information and tools to advance your business.

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japanese flag
  • 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).
Australia flag
  • 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).
Flag of China
  • Process Chart

Chinese NMPA Regulatory Approval Process for Medical and IVD Devices

Our China regulatory process chart offers intuitive, high-level overviews of your paths to product registration.
Clinical Evaluation Report (CER)
  • Guide

What is a Clinical Evaluation Report (CER)?

This guide helps explain how to prepare a Clinical Evaluation Report for medical devices as well as what required updates need to be made.
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