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.


Learning Outcomes

  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.

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