Non-Clinical Assistance
RDEC provides expert support for non-clinical studies, helping ensure your medical devices and combination products meet safety and performance requirements. We collaborate with clients to streamline the non-clinical testing process and coordinate with testing providers to ensure successful outcomes.
- Preclinical Testing Support: Designing and coordinating preclinical testing plans, including in-vitro and in-vivo models, to demonstrate product safety and functionality.
- Material Characterization: Assisting with the evaluation of materials to assess their physical, chemical, and mechanical properties to ensure they meet regulatory and performance requirements.
- Toxicology Studies Management: Coordinating toxicological evaluations to assess the safety of materials and substances used in your product.
- Extractables and Leachables Testing Coordination: Supporting studies to identify potential leachable compounds and ensuring compliance with ISO and FDA requirements.
- Biocompatibility Studies Coordination: Helping ensure materials and components meet biocompatibility standards as per ISO 10993 and other regulatory guidelines.
- Sterilization Validation Testing: Providing support for non-clinical testing of sterilization methods to ensure sterility assurance levels and material compatibility.
- Reporting and Documentation: Assisting in the preparation of detailed reports and documentation to summarize non-clinical study results and provide organized records for internal use or submission purposes.