Pre-Clinical Evaluation and Assessment

This module aims to provide learners with a detailed knowledge of the relevant information required in test protocols and complete test reports for pre-clinical performance evaluation and assessment of technologies in a premarket submission to regulatory bodies. The module will have a particular focus on non-clinical bench performance testing, biocompatibility evaluation, human factors and software verification in validation and will explain the guidance documentation in place by the various regulators for Medical Technologies.

1. Demonstrate a detailed knowledge and understanding of non-clinical premarket submission, types of tests required, and associated standards for medical technologies.

2. Source and interpret, regulations, standards and guidance to design and execute a relevant test (objectives and methods, pre-defined pass/fail criteria, results summary, discussion and conclusions).

3. Critically evaluate test data to inform design improvement of medical technologies.

4. Interpret key clinical terms and demonstrate an ability to prepare a clinical evaluation report on the perofmace of a medical technology.