Non-active medical devices

Non-Active Medical Device Testing

How its tested matters - Your trusted partner

How its tested matters - Your trusted partner

Non-active medical devices play a crucial role in healthcare, requiring rigorous testing to guarantee user safety and intended functionality. TÜV SÜD, with its comprehensive suite of testing services, ensures that your devices meet stringent criteria and standards. Our experts thoroughly analyse physical performance, chemical composition, microbiological factors, and potential risks. Through rigorous tests, we ensure that your medical devices adhere to global regulations and are safe for use in healthcare settings. With TÜV SÜD's proven track record, you can be rest assured that industry professionals and consumers globally will recognize your medical devices for their functionality and safety.

     

WHY CHOOSE TÜV SÜD FOR NON-ACTIVE MEDICAL DEVICES TESTING?

  • Comprehensive Suite of Services

    TÜV SÜD’s test laboratories provide compliance testing, Biocompatibility Testing, Extractables and leachables, MRI safety testing, Microbiology, Transport and simulation, and Sterilization of non-active medical products

  • Global Market Access

    Our technical teams have expertise in National and International standards and can navigate through the regulatory requirements, including high-risks Class III device test testing

  • Board-certified Toxicologists

    TÜV SÜD created a hub of Toxicological risk assessment and biological evaluation with a dedicated team of American board-certified Toxicologists

  • Operational Round-the-Clock

    Our test facilities run 24/7, and we help businesses reduce the product life cycle of testing and validation

  • On-time deliverables with high-quality reports

    A dedicated team for project management and client support, including virtual calls for clarification with our team of experts and post-submission assistance

 

TESTING INFRASTRUCTURE

  • Testing Equipment and Instrumentation
    • LC-MS-QTOF
    • GC-MS/Headspace
    • ICP MS
    • TOC
    • Biosafety Cabinet
    • CO2 Incubators
    • BOD Incubators
    • Shaker
    • Permeability tester
    • Impact tester
    • Precision balances
    • Environmental Chambers
    • Automated Colony Counters
    • ELISA Reader
    • Cooling Centrifuges
  • Testing Services
    • Biocompatibility Testing
    • Extractables and Leachable analysis 
    • Toxicological Risk Assessment 
    • Biological Evaluation plan and Report
    • MRI Safety Testing 
    • Cybersecurity testing 
    • Microbiology
    • Packaging Testing
    • Transport and Simulation 

   

STANDARDS WE TEST AGAINST

  • Major Medical Standards
    • Biocompatibility Testing: ISO 10993 series 
    • Extractables & Leachables Testing: ISO 10993-18 and 17
    • Microbiology: ISO 11137, ISO 17664 and USP<85>
    • Packaging: IEC 60721, IEC 60529, IEC 60068, ISTA % ASTM
    • Cyber Security: IEC 62443
    • MRI Safety: ASTM Series, ASTM F2052, F2213, F2182, F2119, F2503

 

ACCREDITATION FOR THE LAB

  • ISO 17025
  • OECD GLP 
  • DSIR
  • DSCO

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