Biological Safety Evaluation

  • We perform tests, characterization and evaluation of biological safety of medical devices and related manufacturing processes:

    • Using smart strategies instead of head down approach test programs with high associated costs

    • In relation to specific processes and product, considering all available information relating to materials, products and  similar processes

    • In accordance with the directives, regulation and guidelines

    • Defining methods that based on our experience extend far beyond the simple interpretation of the guidelines and the specific regulations

    • With the final goal to ensure conformity of the product and patient safety

    Our main areas of expertise are:

    • Qualification of the biocompatibility of the devices / materials

    • Qualification of procedures for cleaning, packaging, and sterilization

    • Qualification and monitoring of production and packaging systems

    • Validation of reusability

    In particular:

    • Selection of the approach of testing in a product-based or and / or process-based

    • biological and chemical characterization of the profile of solubility, organic and inorganic leachable and extractable carcinogenic substances / impurities of materials (cytotoxicity tests, chemical analysis GC-MS, GC-FID, ICP-MS, et. Al.) (ISO 10993-1, -3 – 5, -7, -10, -11, -12, -13, -14, -18)

    • Stability to corrosion of metallic materials, electrochemical test, immersion (ISO 10993-1, -15)

    • hemocompatibility (ISO 10993-1, -4)

    • biostability of the installations (ISO 10993-1, -6, -13, -15, -18)

    • Overall assessment of the biocompatibility of toxicological risk management (ISO 10993-1, -17), in consideration of the characteristics and toxicological profile of the materials used, the substances released, literature data and experience with the application

    • additional tests of biocompatibility after storage, reprocessing

    We carry out, in accordance with ISO 10993, the following tests to ensure the biological safety and biocompatibility of the analyzed product:

    For any information relating to testing and / or monitoring of the biological safety of a medical device or its production process please do not hesitate to contact us!

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