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25.06.2013 Frankfurt am Main Workshop 8 0

Workshop on FAQ 62304

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Termin
Beginn: 25.06.2013
Ende: 25.06.2013
Veranstaltungs-Sprache
en-US
Veranstaltungsort

Cosmopolitan Restaurant & Konferenz
Im Hauptbahnhof 1
60329 Frankfurt am Main
Deutschland

Beschreibung
Introduction: 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. Target Audience: The workshop is primarily dedicated to Representatives from Healthcare Software Industry, Notified- and Standardization Bodies as well as Consulter.
Veranstalter

VDE-Zentrale

Mitveranstalter

VDE Medtech
VDE Prüf- und Zertifizeriungsinstitut

Kontakte

Dipl.-Ing. Michael Bothe
VDE Prüf- und Zertifizierungsinstitut GmbH
Merianstr. 28
63069 Offenbach

3ztyrv2.s5_yvQAuv.t53 Tel. 0698306220
Fax 0698306526

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