Biocompatibility testing of medical devices is required to establish the safety of medical devices, which is a critical part of the regulatory approval process.  Eurofins Advinus is your ideal service partner to provide biocompatibility testing services to your medical devices for various regulatory and notified bodies. Eurofins Advinus is operational for over 30 years as a premier preclinical contract research organization and the first GLP certified facility in India with extensive historical toxicological data.

We are GLP certified since 1992, AAALAC certified since 2001, ISO 17025 certified and Central Drugs Standard Control Organisation (CDSCO) registered facility for Medical device testing.

Eurofins Advinus has experience and provides exceptional expertise to assist medical device manufacturers in designing thorough, well-constructed testing programs to satisfy regulatory requirements.

Biocompatibility programs follow FDA guidance and the latest ISO 10993 standards.

Cytotoxicity testing

  • Agar diffusion test
  • Agar diffusion with extraction test
  • MEM elution test
  • MTT cytotoxicity test
  • Neutral Red Uptake (NRU) test
  • Colony formation test

Sensitization testing

  • Guinea Pig Maximization Test (GPMT)
  • Buehler Sensitization test
  • Local Lymph Node Assay (LLNA)

Irritation Testing

  • Intracutaneous reactivity test
  • Primary skin irritation test
  • Primary ocular irritation test
  • Primary buccal (mucosal) irritation test
  • Vaginal irritation test
  • Rectal irritation test
  • Penile irritation test
  • In vitro irritation test

Material mediated pyrogenicity testing
Systemic toxicity testing

  • Acute systemic toxicity Test
  • Subacute systemic toxicity testing
    • 28 day (ISO and abridged design) – All routes
    • 90 day (ISO and abridged design) – All routes
  • Chronic systemic toxicity – All routes

Implantation testing

  • Muscle implant for varying periods
  • Subcutaneous implant for varying periods

Hemocompatibility testing

  • Hemolysis test (Direct contact and extract method)
  • Complement Activation Test
  • Coagulation Tests

Genotoxicity testing

  • Bacterial reverse mutation test
  • In vitro mammalian chromosomal aberration test in CHO cells
  • In vitro mammalian cell gene mutation test using the thymidine kinase gene
  • In vitro mammalian chromosomal aberration test in human peripheral blood lymphocytes
  • In vitro mammalian cell micronucleus test
  • In vivo micronucleus test
  • In vivo chromosomal aberration test

Carcinogenicity testing
Ocular biocompatibility test with rabbit eyes as per ISO 9394
Cytotoxicity test of contact lenses in combination with lens care solution as per ISO 18189
US Pharmacopeia-National Formulary Testing

  • USP <87> In-Vitro Biological Reactivity – Cytotoxicity Testing
  • USP <88> In-Vivo Biological Reactivity – Class I–VI Testing