The international standard IEC 62304
"MEDICAL DEVICE software - Software life-cycle processes" provides requirements for the development and maintenance of medical software.
It covers software, both embedded and as a MEDICAL DEVICE. The technically identical EN 62304 standard is harmonized under all MEDICAL DEVICEs directives. In recent years, many questions have come up as to how certain elements need to be understood in the context of the European MEDICAL DEVICE regulatory framework. Experts from European Notified Bodies and European MEDICAL DEVICE industry collected these questions with the objective to clarify those relating to the use of EN 62304:2006 / AC:2008 in the context of the European MEDICAL DEVICEs Directives. Furthermore it intends to provide guidance on some technical matters relevant for application of the standard. The document also aims to be a reference for manufacturers of medical software, as well as for Notified Bodies dealing with medical software.
The workshop is primarily dedicated to Representatives from Healthcare Software Industry, Notified- and Standardization Bodies as well as Consulter.
VDE Prüf- und Zertifizeriungsinstitut