We Also Provide Services LikeRead More
Medical device testing
Medical Device Testing
The safety of medical devices must be established by biocompatibility testing, which is an important aspect of the regulatory licensing process. Mavens is an excellent service partner for biocompatibility testing of medical devices for various regulatory and notified organisations. Mavens has been a leading preclinical contract research organisation and India’s first OECD certified GLP-accredited test facility with extensive historical control data for over 30 years.
Since 1992, we’ve been GLP certified, AAALAC accredited, ISO 17025:2017 certified, and a Central Drugs Standard Control Organization (CDSCO) registered medical device testing center.
To improve your medical device testing strategy, consult an expert.
In the field of medical device testing, we have a team of subject matter specialists. Our testing team has over 100 years of combined experience in biological safety assessment, biocompatibility testing approach, and toxicological result interpretation.
Medical equipment Biocompatibility investigations are carried out in accordance with ISO 10993 guidelines, and the team has experience designing studies for multicomponent and dynamic extraction procedures. The studies are conducted in accordance with current international norms and in accordance with GLP to ensure global acceptance.
Medical device testing includes the following types of tests:
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