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Medical and in-vitro diagnostic devices

With testing facilities and regulatory experts throughout the world, UL offers the most convenient and complete global regulatory access solution for medical and IVD device manufacturers.   UL provides the option of having both integrated test plans for your product testing and integrated quality systems audits, which enable you to satisfy regulatory requirements for multiple countries, all in your local language and time zone.

Services to support access to the major medical markets

United States 

• Dedicated web page for IEC 60601 3rd edition transition
• FDA 510(k) 3^rd party review
• UL classification under IEC/UL 60601
• EMC testing for FCC and 60601-1-2
• Non-Clinical Testing Biocompatibility, packaging validation, shelf life studies, materials characterization

  UL classification under UL 61010 - Lab equipment
• Home healthcare
• Infusion pump performance testing to support FDA submissions
• Human Factors Engineering and Usability to support FDA submissions
• Clinical Investigations, CRO

Canada

• Dedicated web page for IEC 60601 3rd edition transition
• ISO 13485 under CMDCAS
• Testing and classification to Canadian safety standards - CSA C22.2 No 61010 and CSA C22.2 No. 60601

 European Union

• Dedicated web page for IEC 60601 3rd edition transition
• CE Marking Notified Body under MDD and IVDD
• ISO 13485 medical quality system registration
• CB Scheme test certificates and informative reports
• Non-Clinical Testing Biocompatibility, packaging validation, shelf life studies, materials characterization

  EMC testing
• UL-EU mark
• GS mark
• D mark
• Home healthcare
• Infusion pump performance testing to support NB submissions
• Own brand labeling for Notified Body
• Human Factors Engineering and Usability to support Notified Body submissions for CE-Mark
• Clinical Investigations, CRO

Japan

• Testing and certification to JIS standards 60601 and 61010
• PAL 3^rd party approvals for class 2 designated controlled devices
• ISO 13485 under JGMP Ministerial Ordinance 169
• Non-Clinical Testing Biocompatibility, packaging validation, shelf life studies, materials characterization
• EMC testing

Brazil

• Testing to Brazil safety standards NBR/IEC 60601 and NBR/IEC 61010
• INMETRO certification

China, Taiwan, Korea

• Application services for regulatory approvals
• Taiwan technical cooperation program

Additional services to support global regulatory submissions

• CB informative test report
• Global market access
• Instructor led training
• On demand learning and webinars
• ISO 13485 medical quality system registration
• EMC testing and SAR testing
• ISO 14971 risk management registration
• Testing to meet country specific requirements
• Infusion pump performance testing to IEC 60601-2-24 particular standard requirements
• Assessments to IEC 60601-1-6 (Usability) and ISO 62366 for global regulatory submissions