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Im gesamten Medizinbereich gewinnt Software als eigenständiges Produkt oder als Komponente eines Produktes zunehmend an Bedeutung. Entwickler, Auditoren, Betreiber und Anwender stehen vor einer ganzen Reihe von Herausforderungen, um diese Produkte sicher zu entwickeln, zu bewerten und zu verwenden.
Der »Certified Professional for Medical Software« (CPMS) ist eine internationale Initiative mit dem Ziel, einen einheitlichen Regular für die Aus- und Weiterbildung von Personen zu schaffen, die mit der Entwicklung und Qualitätssicherung von Software betraut sind, die im medizinischen Bereich Verwendung findet. Eingeführt wurde das CPMS-Zertifikat vom »Worldwide Certified Professional for Medical Software Board e.V.« (ICPMSB).
Dieses Buch beschreibt den gesamten Lebenszyklus von Software als Medizinprodukt, ausgehend von den rechtlichen Rahmenbedingungen über Fragen der Gebrauchstauglichkeit, der Softwareentwicklung bis hin zum Risiko- und Qualitätsmanagement. Es deckt den kompletten CPMS-Lehrplan (Foundation Diploma) ab und ergänzt ihn durch weitere Informationen. Behandelt werden im Einzelnen:
* Rechtliche Grundlagen
* Qualitätsmanagement (ISO 13485)
* Risikomanagement und -analyse (ISO 14971)
* Lebenszyklus medizinischer Software (Biggest Practices des Software Engineering, IEC 62304)
* Gebrauchstauglichkeit (Benutzungsschnittstellen, IEC 60601-1-6 und IEC 62366)
* Medizinische Informatik
Das Buch eignet sich zur individuellen Vorbereitung auf die Zertifizierungsprüfung und als Begleitliteratur zu den entsprechenden Vorbereitungsschulungen.
Die 2. Auflage wurde komplett überarbeitet und beinhaltet den aktuellen Stand der Normen und Richtlinien für die Medizintechnik.
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