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.
Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.
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.
Emergo assists medical device companies with registration for In-vitro diagnostics (IVDs) with expert knowledge, consulting and document preparation.
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.
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