Biocompatibility & Toxicology Testing

Biocompatibility & Toxicology Testing
Product Description

Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with a unique set of testing requirements, the biocompatibility testing experience can be intimidating. Even after a device has been categorized, a myriad of decisions for each test remains. Generally we recommend customers perform the following for new products:

  • Biological Evaluation Plan (BEP)
  • Product Tests – Biocompatibility (in vivo, in vitro) and Chemistry – Extractables & Leachables (E&L)
  • Toxicological Assessment – Data summary and qualified safety assessment
The biocompatibility team at Nelson Labs will work with you to develop a comprehensive testing plan that’s right for your product. We will also partner with you th

Nelson Labs NV

  • BE
  • 2024
    On CPHI since
  • 4
    Certificates
  • 100 - 249
    Employees
Company types
Academic/Research
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Laboratory Services
Regulatory Affairs
Specifications

Nelson Labs NV

  • BE
  • 2024
    On CPHI since
  • 4
    Certificates
  • 100 - 249
    Employees
Company types
Academic/Research
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Laboratory Services
Regulatory Affairs

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Nelson Labs NV resources (4)

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