Biocomptesting, Inc.
Biocomptesting is a specialized provider of biocompatibility testing services for medical devices, focusing solely on biocompatibility to ensure accuracy, efficiency, and compliance with regulatory standards. They serve startups to global medical device companies, offering tailored testing strategies, cost-effective solutions, and expert guidance to help clients bring their products to market faster and with confidence.
Industries
Services
Biocompatibility testing services
End-to-end biocompatibility services including test strategy development, GLP in vitro and in vivo testing per ISO 10993 and FDA guidance, data analysis, and regulatory-ready report compilation.
Biocompatibility risk assessment and rationale services
Preparation of written rationales, literature and predicate-device reviews, and risk assessment reports to justify reduced testing requirements and support regulatory submissions.
Biocompatibility testing services
End-to-end biocompatibility services including test strategy development, GLP in vitro and in vivo testing per ISO 10993 and FDA guidance, data analysis, and regulatory-ready report compilation.
Biocompatibility risk assessment and rationale services
Preparation of written rationales, literature and predicate-device reviews, and risk assessment reports to justify reduced testing requirements and support regulatory submissions.
Expertise Areas
- Biocompatibility testing and ISO 10993 compliance
- Regulatory strategy and submission support for FDA 510(k) and CE marking
- In vitro and in vivo toxicology studies
- Hemocompatibility and coagulation testing
Key Technologies
- ISO 10993-series biocompatibility assays
- GLP-compliant laboratory practices
- ISO 17025-accredited testing
- In vitro cytotoxicity methods (MEM elution, agarose overlay, direct contact)