ISO 10993-10:2021 Biological evaluation of medical devices Course Overview

The ISO 10993-10:2021 Biological evaluation of medical devices course provides comprehensive training on the principles and practices outlined in the ISO 10993-10 standard, which focuses on tests for irritation and skin sensitization. Learners will gain an in-depth understanding of biological evaluation principles, various biological endpoints, and the selection of appropriate test methods. The course covers the process of biological risk assessment, management, and the creation of biological evaluation reports.

Participants will learn how to develop strategies for the biological evaluation of medical devices, including combination products, biomaterials, and drug-device combinations. Regulatory requirements for the biological evaluation of medical devices are also addressed, ensuring that learners understand the necessary steps to comply with international regulations.

By completing this course, learners will be equipped to conduct thorough biological evaluations, manage risks effectively, and ensure the safety and efficacy of medical devices throughout their lifecycle. This knowledge is crucial for professionals involved in the design, testing, and regulatory approval of medical devices.