Medical Device Testing

Biocompatibility testing of medical devices is required to establish the safety of medical devices has a critical part of the regulatory approval process. Adgyl Lifesciences is your ideal service partner to provide biocompatibility testing services to your medical devices for 510K submission and to various regulatory and notified bodies. The Test Facility, Adgyl is GLP certified since 1992, AAALAC certified since 2001, ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.

The Test Facility, Adgyl has been operational for over 30+ years and Medical Device Testing team has the expertise and experience to deliver superior quality work, on-time reporting at a competitive price for wide range of products (including raw materials) and develop an appropriate testing program for assessing the safety of the Medical Devices as per latest ISO 10993 standards, FDA guidance and other guidelines. The following studies are offered which are performed in compliance with ISO 17025 and/or GLP.

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
  • Invitro 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 in Rat/ Rabbit/ Swine/Sheep/Dog
  • Muscle implant for varying periods (1 week to 2 year)
  • Subcutaneous implant for varying periods (1 week to 2 year)
  • Dental Implants for varying periods (1 week to 2 year)
  • Bone implants for varying periods (1 week to 2 year)
  • Implantation in organs/tissues for varying periods (1 week to 2 year)
Facilities
  • State of the art -surgical suite
  • CathLab; ECHO; Doppler
  • Vascular image analysis
  • Plastic embedding of tissues along with implants
  • Scanning Electron Microscopy
  • Tissue morphometry software
Device Testing
  • Cardiovascular devices
  • Orthopedic segment
  • Gastrointestinal segment devices 
  • Genitourinary segment devices
  • Neurological segment devices
  • Dental devices
  • Other miscellaneous devices

*: Implantation large animals is performed at partner facility

Hemocompatibility Testing
  • Hemolysis test (Direct contact and extract method) in Rabbit/human Blood
  • Complement Activation Test
  • Coagulation Test
  • Platelet Activation Test
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¬†cytogenetic assay
  • In vivo micronucleus test
  • In vivo chromosomal aberration¬†
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 IVI Testing