Sökning: "Soziar Bamyr Hanssen"

Hittade 2 uppsatser innehållade orden Soziar Bamyr Hanssen.

1. 1. AI and Medical Devices – General guidance principles for SMEs to meet the regulatory demands on safety and efficacy in the EU in order to reach the market

   Master-uppsats, KTH/Medicinteknik och hälsosystem

   Författare :Soziar Bamyr Hanssen; [2022]
   Nyckelord :SMEs; AI; AI-based medical device; MDR; SaMD; guideline;

   Sammanfattning : Artificial intelligence (AI) is the study of science, engineering, and the development of intelligent machines. AI is based on human intelligence with the exception that it is not restricted by biologically observable limitations. AI has developed rapidly over the past few years and has become important all over the world. LÄS MER

3. 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 hälsosystem

   Författare :Soziar Bamyr Hanssen; Rosemarie Ohanyan; [2021]
   Nyckelord :IVDD; IVDR; regulations; in-house production; distribution; manufacturing; IVDD; IVDR; regelverk; egentillverkning; distribution; tillverkning;

   Sammanfattning : 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