Mitigate regulatory challenges for seamless market access
Health and life sciences companies are challenged to comply with complex and constantly evolving regulations worldwide. Lack of automation, well-thought-out market access strategies, and local expertise can hinder market access. We provide a global network of experts to support compliance and software to automate regulatory affairs.
Be compliance ready with our experts and robust software
Leverage our global medical market expertise
Our consulting team provides medical market expertise in more than 20 countries.
Simplify product registration
Our consultants have helped register more than 100,000 medical products worldwide.
Automate regulatory compliance
Manage compliance with our software, used by 15,000+ medical device and IVD companies.
Meet our experts
“A well-thought-out regulatory strategy can enable innovation, streamline market access and position your business for sustained growth.”
Evangeline Loh
Senior Manager, Quality & Regulatory Affairs
“We are proud to serve as a trusted resource to help our customers achieve regulatory compliance, working together to make the world a safer place.”
Jennifer Turner
Senior Regulatory Affairs Manager, Product Stewardship | Software & Advisory
How we enable customers to navigate regulatory landscapes
Medical Device and IVD Regulatory Affairs and Quality Consulting
The Emergo by UL team of regulatory affairs experts helps medical device and IVD companies achieve their market access goals and maintain post-market compliance in more than 20 countries.
Global Registration Consulting for Medical Devices and IVDs
Medical market access requires registering products with regulators. Our experts help customers prepare application materials, build quality management system compliance and register their devices worldwide.
In-country Representation for Medical Device Manufacturers
Companies must appoint an in-country representative in each of their target markets to manage compliance. We provide regulatory expertise and represent more than 2,000 medical device and IVD companies in more than 15 countries.
Regulatory Affairs Management Suite (RAMS®)
Emergo by UL offers the Regulatory Affairs Management Suite (RAMS) SaaS platform, enabling customers to automate regulatory affairs processes and leverage our regulatory intelligence across multiple markets.
Medical Device Post-Market Surveillance
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. Emergo by UL supports PMS compliance in multiple markets.
ULTRUS™ ChemADVISOR® Regulatory Database
Companies managing environmental, health and safety (EHS) regulatory compliance can use our ULTRUS ChemADVISOR Regulatory Database, which provides chemical regulatory data on 600,000+ substances.
ULTRUS™ WERCS Studio Chemical Data and Compliance Management
Our ULTRUS WERCS Studio software enables chemical and material data management for compliance, product transparency and sustainability. WERCS Studio uses regulatory data from our ChemADVISOR database.
Chemical Regulatory Advisory Services
We provide expert advisory support to help customers achieve compliance. Our network of experts collaborates with customers to identify chemical compliance actions, create compliance documents and more.
Featured resource
Global Regulatory Compliance for Medical Devices
Our white paper covers developing regulatory strategies for accessing multiple medical markets.
Related regulatory readiness and compliance resources
Related Health and Life Sciences market access offerings
Product Design and Usability
UL Solutions offers human factors engineering advisory and software support to help product developers and R&D professionals lacking internal resources and expertise to develop safer, more effective and more usable medical products
Testing and Certification for Health and Life Sciences
As a global safety science leader, UL Solutions offers robust and impartial third-party testing and certification to industry standards necessary to demonstrate safety and performance claims for their products, crucial for achieving market access.
Comprehensive offerings for the Health and Life Sciences industry
Market Access
UL Solutions provides software and advisory services to support product development and design, testing and certification and expert consulting to support customers regulatory compliance.
Cybersecurity
We offer software, testing and expertise to manage cybersecurity risks and develop safer manufacturing processes under the Industrial Internet of Things (IIoT).
Workforce Training and Competence
We offer learning management software to help companies implement training programs, standardize manufacturing processes and keep pace with regulatory changes.
Supply Chain Resilience
Our software and services provide visibility into firms’ supply chain networks, helping to minimize disruptions and mitigate supplier- and product-related risks.
ESG Stewardship
We offer software and advisory expertise to manage ESG reporting, reduce carbon emissions and more sustainably bring medical products to market.
Learn more
Within UL Solutions, we provide a broad portfolio of offerings to many industries. This includes certification, testing, inspection, assessment, verification and consulting services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers’ brands, UL Solutions has processes in place to identify and manage any potential conflicts of interest and maintain the impartiality of our conformity assessment services.
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Leverage our regulatory expertise
Achieve and maintain medical market access.
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