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Solviva Biomaterials are manufactured in compliance with relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Our biomaterial manufacturing processes are carefully validated, and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Based on biocompatibility testing, Solviva Biomaterials demonstrate no evidence of cytotoxicity, sensitization, irritation or acute systemic toxicity. Detailed results of the following tests are listed in our FDA Device Master Files.
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