The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.
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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.
We can help you design and execute a regulatory strategy across major and emerging medical device markets.
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.
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device.
The purpose of quality audits is to verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.
ANSWERED ON THIS PAGE:
Why do we need ISO 13485 certification?
How will ISO 13485 certification benefit our company?
What is involved in the implementation process?
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?
Learn about Emergo by UL's ISO 14971 risk management training courses for medical device companies.
Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.
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.
Do you sell medical devices but need market access help? Use our regulatory intelligence software to access process charts and global knowledge base tools.
From Algeria to Zambia, we provide custom Regulatory Pathway Reports for almost every country in the world, including Latin America, Southeast Asia, and Africa.
Smart Builders walk you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency and Standard Route, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.
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