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1. MDR’s Impact on Standards Usages and the Relevance for In-house Production of Medical Devices
Kandidat-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : The current regulation for Medical Devices (MDR) entered into force on 26 May 2021, which has entailed major changes to relevant legislation for in-house production of medical devices in healthcare. The relevance for updating existing, or the development of new standards is currently not well documented and determined and the aim of this report is to make recommendations for how the development of standards may be improved and how departments of medical technology (DMT) in practice apply standards at in-house production of medical devices. LÄS MER