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*.
Our consulting team provides medical market expertise in more than 20 countries*.
Our consultants have helped register more than 100,000 medical products worldwide*.
Manage compliance with our software, used by 15,000+ medical device and IVD companies.
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*.
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*.
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*.
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*.
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*.
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.
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.
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.
“A well-thought-out regulatory strategy can enable innovation, streamline market access and position your business for sustained growth.”
“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.”
Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.
Learn more about optimization for global vigilance reporting.
Download our white paper, PFAS Regulations and Strategies for Compliance, to learn more about supply chain challenges and opportunities.
Our white paper covers developing regulatory strategies for accessing multiple medical markets.
Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.
Achieve and maintain medical market access.
* Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy 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 brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR, IVDD or IVDR Notified Body, UKCA MD Approved Body or MDSAP Customers.
