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Qualitätsmanagementsysteme für Medizinprodukte. Die Anforderungen der ISO_13485
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ISBN10: 3346521982
ISBN13: 9783346521989
Publisher: Grin Verlag
Published: Nov 22 2021
Pages: 46
Weight: 0.16
Height: 0.11 Width: 5.83 Depth: 8.27
Language: German
ISBN13: 9783346521989
Publisher: Grin Verlag
Published: Nov 22 2021
Pages: 46
Weight: 0.16
Height: 0.11 Width: 5.83 Depth: 8.27
Language: German
Studienarbeit aus dem Jahr 2016 im Fachbereich Gesundheit - Gesundheitswesen, Note: 1,0, Hochschule Magdeburg-Stendal; Standort Magdeburg (Hochschule), Veranstaltung: Management im Gesundheitswesen (M. A.), Sprache: Deutsch, Abstract: Diese Hausarbeit beschäftigt sich primär mit der ISO 13485 für Qualitätsmanagementsysteme (QM-Systeme) für Medizinprodukte und deren Anforderungen für regulatorische Zwecke. Sie gliedert sich in fünf Kapitel. Nach der Einleitung stellt Kapitel 1 zunächst das Qualitätsmanagement (QM) für Medizinprodukte mit seinen gesetzlichen Rahmenbedingungen sowohl auf internationaler, europäischer als auch nationaler Ebene vor. Ferner wird näher darauf eingegangen, welchen aktuellen Stand das derzeitige Normenverfahren hat und auch welche Auswirkungen fortgeschriebene Rechtsbestimmungen hierauf nehmen. Darüber hinaus wird auch auf Schnittstellen und Unterschiede zu anderen QM-Systemen im Gesundheitswesen Bezug genommen. Das Kapitel 2 dieser Hausarbeit beschreibt die derzeit gültige internationale Norm ISO 13485 (3te Ausgabe) und gibt einen Ausblick über die zukünftigen Anforderungen durch diese Norm. Kapitel 3 konzentriert sich inhaltlich auf die deutsche DIN EN ISO 13485. Diese Norm nennt Anforderungen an ein QM-System, kennzeichnend für alle Medizinprodukte in Deutschland. Das Kapitel 4 zeigt anhand eines Betriebes der Orthopädieschuhtechnik für Sonderanfertigungen - als Praxisbeispiel für das Gesundheitshandwerk - auszugsweise, inwiefern dort die DIN EN ISO 13485 Einfluss auf die Qualität nimmt. Die Darstellung konzentriert sich dabei in erster Linie auf die Erfüllung der gesetzlichen Anforderungen. Das Fazit in Kapitel 5 zieht schlie lich Schlussfolgerungen, insbesondere unter Berücksichtigung des Praxisbeispiels aus Kapitel 4. Mit dem Vertrag von Lissabon haben die Gesetzgeber auf europäischer Ebene auf die komplette Rechtsprechung Einfluss genommen. Fest steht, dass zur Sicherstellung eines hohen Qualitäts- und Sicherheitsstandards für Medi
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