Medical Services

UL's complete regulatory solution for medical device manufacturers

Regulatory Services

• 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 & Certification

• Biocompatibility, Sterilization, Microbiology, & Analytical Testing
• Quality management systems - ISO 13485
• CB test reports and certificates
• Laser services
• Product testing and certification to UL60601
• 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)