This introductory course aims to orientate you to the regulatory landscape in which healthcare technologies sit. This will include an introduction to relevant regulatory bodies and their scope, the classification systems applied to healthcare technologies and the standards and processes which are used to evaluate these technologies across their lifecycle. These insights will enable you to understand the demands of regulations upon manufacturers and adopters as they plan their innovation activities. Students will also develop the foundation for further training in standards auditing and other professional roles in healthcare quality.

A key component of this module is the focus on Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). Supported by a range of international guest speakers from policy and industry, the content will reflect the latest trends and regulatory updates in these rapidly evolving areas, not only helping you to understand existing frameworks but also to anticipate changes in regulations as technologies advance. This will provide students an up-to-date understanding of rapidly evolving regulations in technologies attracting global investment and interest.