Biocompatibility testing is essential to establish the safety profile of medical devices and is a critical component of the global regulatory approval process.
Eurofins Advinus, in collaboration with its trusted partner laboratory Adgyl Lifesciences, offers comprehensive biocompatibility testing services tailored to meet the requirements of various international regulatory and notified bodies.
With a legacy of over 30 years as a leading preclinical contract research organization, Eurofins Advinus was the first OECD-certified GLP-accredited test facility in India, supported by extensive historical control data and a proven track record in regulatory studies.
Certifications & Accreditations
Services delivered via Adgyl Lifesciences are conducted in facilities that are:
- GLP certified since 1992
- AAALAC accredited since 2001
- ISO/IEC 17025:2017 certified
- Registered with CDSCO for medical device testing
Our testing services are led by a team of subject matter experts with a combined experience of 100+ years in biological safety evaluation, biocompatibility strategies, and toxicological risk assessments.
Medical device biocompatibility studies are conducted according to ISO 10993 standards and are designed to accommodate multicomponent systems and dynamic extraction processes.
Medical Device testing involves the below category of testing:
Biocompatibility Testing
(Offered through a partner laboratory, Adgyl Lifesciences.) Our services include:
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
- Systemic toxicity – Dual route
Implantation Testing
- Muscle implant for varying periods
- Subcutaneous implant for varying periods
- Bone and Ocular Implantation 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
Ocular Biocompatibility Testing
- Determination of biocompatibility by ocular study for ophthalmic optics — Contact lenses and contact lens care products as per ISO 9394.
- Cytotoxicity testing of ophthalmic optics — Contact lenses and contact lens care products 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
Physical & Biological Performance*
To help you with your research, we offer preclinical services for Performance, Biocompatibility & Safety Evaluation of medical devices and therapeutics (ISO 10993, ISO 25539-2: 2012 and 21 CFR 58/GLP).
Cardiovascular Devices
- Cardiac rhythm/ Flow management devices (Defibrillator & Pacemaker)
- Interventional cardiac devices (Stents, Catheters & Angioplasty Balloons)
- Cardiac monitoring/ Diagnostic devices (Telemetry Systems)
- Peripheral vascular devices (Stents, Grafts & Balloon Catheters)
- Electrophysiological devices (RF ablation & Laser Catheters, 3D Mapping Systems)
- Prosthetic devices and ventricular function devices (Prosthetic Valves & VAD)
Integumentary Implant Devices/ Therapeutics
- Hemostats/ Hemosealants and Cellular implant therapies for wound healing
*Test is performed at our sister/partner lab