We call ourselves ‘specialists’, who are informed and vigilant about the different industries that need biocompatibility testing for developing their medical devices. We understand the implications of each medical industry and how specialized services will benefit them. Our experienced professionals are trained in designing and conducting biocompatibility testing as per different industry sectors.
Some of the legacies testing labs are claiming to be skilled and adept at biocompatibility testing, but the question is – Are they up-to-date with the standards? Can they design the testing protocols as per the needs of different sectors of the industry? Do they have the best-in-class facility? Do they know the challenges of devices in different industries? Biocomptesting.com is well versed in addressing the subtle nuances of each of the medical device industries’ sub segments and stands as an undisputed service provider.
IN VIVO TESTING |
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| SENSITIZATION | IRRITATION | IMPLANTATION | TOXICITY | GENOTOXICITY | THROMBO RESISTANCE |
|---|---|---|---|---|---|
| Guinea Pig Maximization | Intracutaneous reactivity | Subcutaneous | Acute systemic toxicity | Bacterial reverse mutations (AMES) | Models: Canine, porcine, Ovine |
| Buehler | Vaginal mucosal Irritation | Intramuscular | Subacute /subchronic toxicity | Chromosomal Aberration | Standard and custom |
| Bone | Chronic toxicity | Murine Mouse Lymphoma | |||
| Material mediated pyrogenicity | Peripheral blood mouse micronucleus | ||||
IN VITRO TESTING |
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| CYTOTOXICITY | HEMOCOMPATIBILITY | ||||
|---|---|---|---|---|---|
| ISO MEM Elution | Hemolysis –ASTM (Direct and extract) | ||||
| Agarose Overlay | Complement activation (C3a and SC5b-9) | ||||
| Direct contact | Partial Thromboplastin Time (ASTM –PTT) | ||||
| Liquid or solid cytotoxicity | Prothrombin Time Assay (PT) | ||||
| Coagulation assays | |||||
Biocomptesting.com has already conducted biocompatibility testing for device in the following industries:
- Cardiology
- Dental Medicine
- ENT
- Urology
- Orthopedics
- Gynecology
- Neurology
- Oncology
- Ophthalmology
- Body wear devices