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WebJun 6, 2024 · Sie beschreibt darin, wann Sie eine erneute 510(k) Einreichung (Premarket Notification) benötigen und wann Sie die Änderungen „nur“ dokumentieren müssen.. 1. Was ein Software Change ist a) Software Changes im „Scope“ des Guidance Documents. Unter einem „Software Change“, der in den Anwendungsbereich des Guidance Documents fällt, … WebSchwerpunkt auf der EN ISO 9241-110 wird ein Überblick über Usability-Fragebögen und Kriterien für deren Qualitätsbeurteilung gegeben. Dann werden das Design der … chuck hedlund conservation
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