The course covers the regulations for medical devices and how authorities and organisations work in the field. It includes risk analysis, accidents and liability, as well as the manufacture, trade and use of medical devices, including in vitro diagnostics under EU regulations. The course also covers medical technology operations in healthcare, including MTA organisation and public procurement. The student develops the knowledge to work according to laws and regulations in public healthcare and the medical technology industry, and to understand the link between regulations and quality systems. The course gives the ability to identify, evaluate and manage risks, as well as basic knowledge of technical maintenance according to applicable standards. Study visits, lab work and practical exercises are included.
The course covers the regulations for medical devices and how authorities and organisations work in the field. It includes risk analysis, accidents and liability, as well as the manufacture, trade and use of medical devices, including in vitro diagnostics under EU regulations. The course also covers medical technology operations in healthcare, including MTA organisation and public procurement. The student develops the knowledge to work according to laws and regulations in public healthcare and the medical technology industry, and to understand the link between regulations and quality systems. The course gives the ability to identify, evaluate and manage risks, as well as basic knowledge of technical maintenance according to applicable standards. Study visits, lab work and practical exercises are included.
