Biocompatability & Medical Devices Testing
Biocompatability & Medical Devices Testing Services in India
Numerous medical devices necessitate biocompatibility testing in accordance with the International Organization for Standardization (ISO) standard 10993. The biological endpoints for such testing vary depending on the type of medical device under examination. However, ISO 10993 establishes criteria for both in vitro and in vivo assessments. Vipragen, with its numerous global facilities, comprehensive in vitro to in vivo capabilities, and extensive expertise in biocompatibility testing aligned with regulatory standards, can optimize and expedite your medical device testing program.
Biocompatibility Testing for Medical Devices
The wide range of formats and materials utilized in the development of medical devices presents a challenge in designing tests that effectively assess their safety and efficacy. From polymers, metals, ceramics, biodegradable, and innovative materials to various solid and porous scaffolds, creams, gels, liquids, fabrics, cements, coatings, and surface treatments, we have encountered diverse compositions. Whether you require testing for raw plastic materials or a finalized device, our experts can formulate a suitable biocompatibility testing plan by leveraging our extensive portfolio of in vitro and in vivo services.
Biocompatibility Testing for Medical Devices
- » In vitro cytotoxicity (GLP, ISO 10993-5)
- » Sensitization (GLP, ISO 10993-10)
- » Irritation or intracutaneous reactivity (GLP, ISO 10993-10)
- » Pyrogenicity study in rabbits (GLP, ISO 10993-11)
- » Genotoxicity (GLP, ISO 10993-3)
- » Systemic toxicity
- » Hemocompatibility
- » Carcinogenicity and reproductive toxicity