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.
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.
RAMS can help you navigate complex medical device and IVD regulatory affairs activities with powerful tools to simplify your work and provide market insights.
Scalable RA/QA SaaS solution for medical device and IVD manufacturers
In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Mi
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.
Emergo by UL offers qualified in-country representative and regulatory representation for over 500 medical device companies worldwide.
Explore how we can support you by becoming your India Authorized agent for your medical devices and IVDs.
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.
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.