Bio – Compatibility Studies of Medical Devices
(As per ISO 10993, USFDA and EU MDR Guidelines)
  • Anti Cancer Activity (In – Vitro/ In Vivo)
  • Cytotoxicity Study (In-Vitro)
  • Sensitization Study (In-Vitro & In-Vivo)
  • Irritation or Intracutaneous Reactivity (In-Vitro & In-Vivo)
  • Systemic Toxicity Study (Acute, Sub-Acute, Sub-Chronic, Chronic)
  • Genotoxicity (In-Vitro & In-Vivo)
  • Implantation
  • Hemocompatibility Study
  • Pyrogen Testing
  • Degradation & Toxico-kinetic Study
  • Carcinogenicity test
  • Reproductive / Developmental toxicity

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