This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course distance-learning activities will also be available for the interested participants.
On successful completion of this Module the student should be able to: Describe and define the field of medical devices, the distinguishing features of medical device technologies, industries and regulatory framework as compared to medicinal products. Interpret the conformity assessment of medical devices based on essential requirements. Categorise medical device products according to the relevant classification and demarcation principles. Describe and illustrate non-clinical and clinical development of medical devices, standardisation and use of standards: European standards, national standards, ISO/IEC standards and harmonised standards. Quality management. Appraise the vigilance and risk management programmes for medical devices. Interpret the principles underlying the compilation of technical dossier/design dossier. Appraise the combined pharmaceutical, clinical pharmacological and technological requirements for the development of medicine-medical device combinations. Evaluate the need and requirements for the joint development of targeted medicine therapy and the related companion diagnostics. Assess the medical needs and clinical significance of emerging technologies. Estimate the requirements for the Health Technology Assessment of medical devices.