Complete regulatory solution

UL provides the health sciences industries with end-to-end regulatory and certification services for global markets.

Regulatory services

• Program requirements
• US -- FDA 510(k) review and inspections
• SFDA application services for China
• Europe -- Notified body for In Vitro Diagnostic Directive (IVDD) and Medical Device Directive (MDD)
• Canada -- ISO 13485 certification under the CMDCAS program
• Japan -- JIS testing and evaluation, PAL third-party certification
• INMETRO mark for Brazil
• Taiwan Technical Cooperation Program for European Manufacturers

Testing, evaluation and certification

• Biocompatibility, Sterilization, Microbiology and Analytical Testing
• Quality management systems -- ISO 13485
• CB test reports and certificates
• Laser services
• Product testing and certification to UL 60601
• Product safety testing and certification to UL 61010

Knowledge solutions

• Gap analysis and other services for risk management systems -- ISO 14971
• On-site standards training workshops and public seminars
• International certification training workshops

Available downloads

• Download UL Medical Device Services brochure (PDF)