Demonstrating the safety and performance of non-active surgical implants relies on rigorous preclinical data, guided by constantly evolving standards and guidelines. The 2024 version of ISO 14630 and the 2025 Team-NB best practices provide key details for compiling technical documentation in accordance with Regulation (EU) 2017/745.
This newsletter aims to help manufacturers understand and structure the preclinical data to be included in their technical documentation. It explains what data are expected, how tests should be conducted, what justifications are required and the specificities related to devices used in combination or to the demonstration of stability.
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