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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by EMERGO by UL

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow.

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Establishing a QMS

Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues

EMERGO by UL
October 15, 2021
So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, marketing, shipping, and distributing your medical devices. But wait, a host... Read More
Establishing a QMS

European Authorized Representative for Medical Device Companies

EMERGO by UL
October 12, 2021
ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Can I appoint a distributor as my representative? What happens if I... Read More

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