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.
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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.
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Our global consulting team works from 20+ offices on six continents.
We are experts in European medical device and IVD compliance. We'll help you navigate regulatory changes in the EU.
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
Compliance support for Clinical Evaluation Reports (CERs), Revision 4 standards and EU Medical Devices Regulation (MDR 2017/745).
Learn which cosmetic and aesthetic products fall under EU MDR requirements and how your company should prepare for MDR compliance.
Learn how we can assist with European medical device vigilance and adverse event reporting, FSCA reports, post-market monitoring and creating vigilance procedures.
European authorized representative (EC REP) for medical device and IVD companies. Official EU Authorized Representative for 1,000+ manufacturers worldwide.
Emergo has a well-established presence in the EU with offices in the UK, Germany, France, and The Netherlands. We have assisted hundreds of medical device manufacturers with CE compliance for Europe.
We help medical device and IVD companies prepare Technical Files and Design Dossiers to obtain CE Marking. Learn more about our Technical File services.
ANSWERED ON THIS PAGE:
What is the regulatory process for IVDs in Europe?
What is the European classification scheme for IVDs?
How will IVD requirements change under the new In-Vitro Diagnostic Regulation (IVDR)?
Emergo assists medical device manufacturers with post-market clinical follow-up (PMCF) studies, investigations, clinical trial management, data validation and more.
Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition and avoid unforeseen challenges.
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