Medical Device Testing Services
ZRCS provides a comprehensive range of medical device testing solutions required by relevant regulatory framework worldwide. We offer a complete biocompatibility and chemical characterization testing package for medical devices through our partner lab’s state-of-the-art laboratories, and high standards of data and quality reporting to address the testing needs of small and large-scale manufacturers.
Our team of chemists, veterinarians, scientists, toxicologists and regulatory affairs consultants with years of experience are well equipped with the technical, pre-clinical and regulatory expertise required to thoroughly evaluate biocompatibility and chemical characterization test results of medical devices for suitability across global markets. At Zyirn, we provide end-to-end support to meet your project goals, while ensuring that project timelines are met with predictability and diligence.
ZRCS provides the following biological risk assessment tests to help manufacturers meet biocompatibility testing requirements of the International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM).
- Cytotoxicity – ISO 10993-5
- Genotoxicity – ISO 10993-3 & FDA
- Hemocompatibility – ISO 10993-4 & ASTM
- Irritation – ISO 10993-10
- Sensitization – ISO 10993-10
- Systemic Effects or Systemic Toxicity and Pyrogenicity – ISO 10993-11 and ASTM
- Implantation – ISO 10993-6
- Toxicological Risk Assessment – ISO 10993-17
- Sterility Testing – ISO 11737 series
- Sterile Barrier System – ISO 11607 & EN 868 series
At ZRCS, our comprehensive chemical characterization services for medical devices according to ISO standards include:
- Chemical Characterization of Materials (ISO 10993-12, 18, 19)
- Identification and Quantification of Degradation Products (ISO 10993-13, 14, 15)
- Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
- Ethylene Oxide Sterilization Residuals (ISO 10993-7)
Please feel free to connect with us if you have any of the above business requirements to discuss our services and any questions you may have regarding your project needs.