Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals

• Main Authors: Juhamatti Huusko (Author), Ulla-Mari Kinnunen (Author), Kaija Saranto (Author)
• פורמט: ספר
• יצא לאור: BMC, 2023-03-01T00:00:00Z.
• נושאים: article
• גישה מקוונת: Connect to this object online.

Abstract Background In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease....