Biocompatibility testing 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 OECD certified GLP-accredited test facility in India with extensive historical control data.
We are GLP certified since 1992, AAALAC accredited since 2001, ISO 17025:2017 certified and Central Drugs Standard Control Organisation (CDSCO) registered facility for Medical device testing.
Expert Review – To optimize your medical device testing strategy.
We have a team of subject matter experts in the field of medical device testing. Our testing team has accumulated experience of 100+ years in Biological safety assessment, Biocompatibility testing strategy and evaluation of toxicological results.
Medical device Biocompatibility studies conducted as per ISO 10993 standards and team has experience in design of studies for multicomponent and dynamic extraction processes. The studies performed comply with current international guidelines and are performed in compliance to GLP to ensure worldwide acceptability.
Medical Device testing involves the below category of testing:
Biocompatibility Testing
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