Medical devices

UL offers the most convenient and complete global regulatory access solution for medical device manufacturers, with testing facilities and regulatory experts throughout the world. With UL as your partner, you have a single point of contact to manage your project delivery team, fluent in your language and business practices.

The UL advantage

• UL supports the medical device industry with end-to-end global regulatory solutions including the first ISO 14971 registration service
• One provider for access to all of the major markets including United States, Europe, Canada, Japan, Brazil, Taiwan and China
• Dedicated local project management and technical teams
• Decades of experience in the medical device industry
• Experts who contributed to the development of US and international regulatory schemes
• A more efficient compliance process via combined audits for regulatory (FDA, INMETRO, CMDCAS), registration (ISO 13485), and certification services (CE, UL, cUL, CB, CCC)
• Network of knowledge spanning 71 countries
• UL 61010 categories that align with health care applications, easy to distinguish by health care purchasing personnel
• Certification services for all your global technical file submissions: IEC 60601, biocompatibility, EMC, software, lasers, and more

Integrated test plans so you have access to global markets with one set of tests for multiple certification marks as part of UL's Global Market Access program