Executive Certificate in Regulatory Requirements of IVD and Software as a Medical Device (Competence)

This Executive certificate will provide a fundamental understanding of the principles behind effective regulation of IVD devices, and cover an overview of the technical documentation and available international standards. This enables an informed decision when planning for the development, market entry and management of IVD devices. This Executive Certificate also aims to provide a better understanding of regulations for Software as a Medical Device (SaMD) technology, including requirements for safety assessments, that will aid in the development, market entry and utility of SaMDs.