Complete regulatory solution for global market approvals
UL supported Skanray, a start-up medical device manufacturer in an emerging market to obtain their ISO 9001, ISO 13485, CE Marking, FDA 510(k) certifications and position them for international expansion.
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- Click here to download the case study paper (PDF format)
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 and CE Marking for In Vitro Diagnostic Directive (IVDD) and Medical Devices Directive (MDD)
- Canada -- ISO 13485 certification under the CMDCAS program
- Japan -- JIS testing and evaluation, PAL third-party certification
- Brazil - INMETRO Certification and testing
- Taiwan Technical Cooperation Program for European Manufacturers
Testing, evaluation and certification
- Continua certified testing laboratory
- Human Factors Engineering assessment to ISO 62366 and IEC 60601-1-6
- Medical Device software certification
- Biocompatibility, Sterilization, Microbiology and Analytical Testing
- Quality management systems -- ISO 13485
- CB test reports and certificates
- Product testing and certification to UL IEC 60601
- Product safety testing and certification for laboratory equipment to UL IEC 61010
- EMC testing and certification
- Wireless security testing
- Laser testing
- Testing to UL 1069, UL 1637 and UL 2560 for Nurse and Emergency Call Equipment
Clinical investigations
Knowledge solutions
- eHealth, Mobile Health (mHealth), Interoperability and Health Information Technology
- Gap analysis and other services for risk management systems -- ISO 14971
- On-site standards training workshops and public seminars
- International certification training workshops
