Sökning: "Regulation EU 2017 746"
Hittade 3 uppsatser innehållade orden Regulation EU 2017 746.
1. Approved medicinal products with potential companion diagnostic tests : An Inventory of the Swedish/European drug market
Master-uppsats, Uppsala universitet/Institutionen för farmaceutisk biovetenskapSammanfattning : The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. LÄS MER
2. Konsekvenserna av (EU) 2017/746- förordningen på tillverkning och användning av medicintekniska produkter för in vitro-diagnostik inom Karolinska Universitetssjukhuset
Kandidat-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : In collaboration with the Karolinska University Hospital, this research was carried out with the aim of executing a consequence analysis of the new regulation (EU) 2017/746. The consequences of the regulation regarding access, distribution, manufacturing and in-house production of in vitro diagnostic products were examined for various departments at the Karolinska University Hospital. LÄS MER
3. Traceability of Medical Devices Used During Surgeries : A Study of the Current Traceability System at the Karolinska University Hospital in Solna and Research of Improvement
Master-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : The last few decades' development of technology has greatly affected healthcare. The implementation of technology in healthcare has advanced and improved it immensely, but it has also brought a new level of complexity. One of the modern issues introduced to healthcare is the traceability of medical devices. LÄS MER
