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eurofins

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Eurofins Medical Device Testing is ISO 17025 accredited and has expertise in a wide range of products and manufacturing processes to help assess the risks of a new device design or process change, and develop an appropriate testing program for assessing the safety of your products.

From chemical characterization of degradation products and extractables and leachables testing, to toxicological risk assessments and biological evaluations, our veterinarians, chemists, and toxicologists can facilitate the appropriate testing to best support your international regulatory submissions. 
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Choose Eurofins Medical Device Testing to help you:
✔  Evaluate the biocompatibility of your new device
✔  Assess the impact of a design change or new manufacturing process on your device’s safety
✔  Evaluate new raw material suppliers
✔  Consider effects of sterilization techniques or long-term material stability
✔  Generate toxicology reports
✔  Review the biocompatibility evaluations for your international regulatory submissions
✔  Establish biological safety plans and conduct gap analyses of existing biocompatibility dossiers

​https://www.eurofins.com/medical-device/services/biocompatibility-testing/
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search