Preclinical

ZURKO RESEARCH

What kind of services do we offer?

The potential biological risks of contact between patients and medical devices must be assessed according to the established protocols prior to clinical application. As a testing laboratory, ZURKO RESEARCH selects and performs the necessary biocompatibility tests for each product, as well as any other preclinical tests necessary to ensure their efficacy and safety.

BiocompatibilityISO 10993

  • Cytotoxicity (NRU, MTT, etc.)
  • Sensitization (GMPT, LLNA, etc.)
  • Irritation: dermal, intradermal, oral, nasal, eye, vaginal and other mucous membranes)
  • Acute toxicity
  • Systemic toxicity: subacute, subchronic, chronic
  • Implantation
  • Effects of implantation combined with Systemic Toxicity
  • Genotoxicity
  • Hemocompatibility
  • Pyrogenicity
  • Biological Assessment Report

Other preclinical tests

Complimentary clinical tests

  • Stability testing (accelerated, shelf-life, in-use, etc.)
  • Antimicrobial preservative efficacy testing
  • Disinfectant efficacy testing for medical devices
  • Efficacy testing with cell cultures
  • Bactericidal/bacteriostatic activity of surfaces, substances and formulations


Quality control and validations

    • Microbiological testing of products (bioburden, sterility, LAL test, etc.)
    • Microbiological testing of manufacturing areas;
      • Production water testing
      • Ethylene oxide residual testing
      • Chemical parameter testing (HPLC, GC- MS, ICP-MS)
      • Heavy metals