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Testing of Medical Devices

Biocompatibility Testing of Medical Devices is required to establish the safety of medical devices and is a critical part of the regulatory approval process. Leveraging on its Toxicology and Safety experience and credibility of over three decades, Adgyl Lifesciences is your ideal partner to provide Biocompatibility testing services toward the development of your Medical Device programs, The data can be used for 510K submissions, and to various regulatory and notified bodies. The Test Facility, Adgyl Lifesciences, is GLP certified since 1992, AAALAC certified since 2001, and is an ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.

The Adgyl Lifesciences’ Medical Device Testing team has the expertise and experience of 30 years of GLP Testing, to deliver superior quality work at a competitive price and in a time-effective manner. The Team, with an accumulated experience of 100+ years in Biological safety assessment, Biocompatibility testing strategy and evaluation of toxicological results. can help develop -an appropriate testing program for assessing the safety of – Medical Devices as per the latest ISO 10993 standards, FDA guidance and other guidelines, and are performed in compliance with GLP to ensure worldwide acceptability.

The following studies are offered that comply with ISO 17025 and/ or GLP

Device Testing
  • Cardiovascular devices
  • Orthopedic segment devices
  • Gastrointestinal segment devices 
  • Genitourinary segment devices
  • Neurological segment devices
  • Dental devices
  • Other miscellaneous devices
Cytotoxicity Testing as per ISO 10993-5
  • Agar Diffusion Test
  • Agar Diffusion with Extraction Test
  • MEM Elution Test
  • MTT cytotoxicity Test
  • Neutral Red Uptake (NRU) Test
  • Colony formation Test
Sensitization Testing as per ISO 10993-10
  • Guinea Pig Maximization Test (GPMT)
  • Buehler Sensitization Test
  • Local Lymph Node Assay (LLNA)
Irritation Testing as per ISO 10993-10
  • 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 as per ISO 10993-11
  • Acute Systemic Toxicity Test
  • Sub-acute 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 as per ISO 10993-6
  • Muscle implant for varying periods (1 week to 2 years)
  • Subcutaneous implant for varying periods (1 week to 2 years)
  • Dental Implants for varying periods (1 week to 2 years)
  • Bone implants for varying periods (1 week to 2 years)
  • Implantation in organs/ tissues for varying periods (1 week to 2 years)

*: Implantation of large animals is performed at a partner facility

Hemocompatibility Testing as per ISO 10993-4
  • Hemolysis (Autian Method)
  • Indirect-Rabbit Blood
  • Direct-Rabbit Blood 
  • Hemolysis Complete (Direct and Indirect) in Rabbit Blood (ASTM Method)
Genotoxicity Testing as per ISO 10993-3
  • 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 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 IVI Testing
  • 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