Underwriters Laboratories Inc.

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Medical Device Services

Simplifying the complexities of compliance on a global scale

UL offers the most convenient and complete global regulatory access solution for medical device manufacturers, staffed with regulatory experts in eight locations throughout the US. With UL as your partner, you are provided with 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 the US, 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
  • Integrated Test plans so you have access to global markets with one set of tests for electrical safety, biocompatibility, EMC, software, lasers, and more.