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Klinische Software als Medizinprodukt: Rechtliche Situation und Auswirkungen der neuen EU-Richtlinie 2007/47/EG
Paperback
Medical ReferenceTechnology & Engineering
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ISBN10: 3640978870
ISBN13: 9783640978878
Publisher: Grin Verlag
Published: Aug 18 2011
Pages: 68
Weight: 0.22
Height: 0.16 Width: 5.83 Depth: 8.27
Language: German
ISBN13: 9783640978878
Publisher: Grin Verlag
Published: Aug 18 2011
Pages: 68
Weight: 0.22
Height: 0.16 Width: 5.83 Depth: 8.27
Language: German
Studienarbeit aus dem Jahr 2011 im Fachbereich Medizin - Biomedizinische Technik, Note: A, UMIT Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik, Sprache: Deutsch, Abstract: Zusammenfassung Die Richtlinie 2007/47/EG ändert mehrere bestehende Richtlinien. Ziele der Arbeit sind die Überprüfung auf inhaltliche Übereinstimmung betroffener EU-Richtlinien mit den nationalen Umsetzungen in Deutschland und Österreich, sowie die Evaluierung der Auswirkungen der RL 2007/47/EG auf den Rechtsbestand, die Hersteller und die Betreiber von Medizinprodukten. Insbesondere in der österreichischen Umsetzung finden sich Abweichungen in Details. Diese sind durch die nicht vorgenommene Unterteilung in Gesetze über Medizinprodukte, In-Vitro Diagnostika und aktive implantierbare medizinische Geräte zu begründen. Zentrale Auswirkung der RL 2007/47/EG ist die Betrachtung von eigenständiger Software - unter Voraussetzungen - als Medizinprodukt. Für Hersteller ergibt sich durch erforderliche Konformitätsbewertungsverfahren ein erhöhter Aufwand. Dieser kann durch modulares Produktdesign minimiert werden. Für Betreiber ergeben sich erhöhte Prüf-, Dokumentations- und Schulungsverpflichtungen.
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