The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.
Comprehensive service offerings at every point in the product life cycle.
A platform of digital products to improve, simplify and automate RA/QA activities
Emergo by UL's new human factors tool - provides training, tools, and resources.
Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
The latest industry news and insights from our global team.
Stay informed with the most read RA/QA medical device newsletter.
TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
Information and tools to advance your business.
Learn from our experts through live events.
Our global consulting team works from 20+ offices on six continents.
From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.
We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.
Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.
Our US consulting team has extensive experience with the FDA Q-Sub process for medical devices. We can assist you with this critical step as part of the FDA clearance process.
Learn how we can assist medical device and IVD companies in complying with QSR audits and implementing a quality management system under current GMP standards.
Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 implementation and compliance.
FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo by UL.
ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.
ANSWERED ON THIS PAGE:
What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?
Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.
Learn how using our internal and gap audit services to meet MDSAP specifications can improve your global market access efforts for medical devices and IVDs.
Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.
ANSWERED ON THIS PAGE:
How does the US FDA UDI system work?
When must we comply with UDI system requirements?
Which device classifications need to comply with UDI requirements?
Smart Builders walk you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency Routes, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.
Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.
We'll review your message carefully and get back to you as quickly as possible. To help ensure that you receive our reply, please add our domain @emergo.ul.com to your list of approved contacts.