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Die Plattform modelliert Systeme von Medizinprodukten und ihre Abhängigkeiten als Graph und bildet sie in strukturierter, nachvollziehbarer Form ab. So erkennen Teams kritische Risiken früh, verstehen, wie sich Fehler im gesamten System ausbreiten, und wägen Design-Entscheidungen fundiert ab, bevor wichtige Festlegungen unumkehrbar werden.\u003C\u002Fp>","full_html",{"__typename":294,"id":295,"columns":296,"listItems":297,"text":314,"title":315,"variant":316},"ParagraphPgContentList","35494","3col",[298,304,309],{"id":299,"icon":225,"link":225,"logo":225,"media":225,"text":300,"title":303},"35491",{"value":301,"processed":301,"format":302},"\u003Cp>Kontinuierliche Risikoanalyse auf Systemebene nach ISO 14971 läuft bis zu 10× schneller als klassische, dokumentenbasierte Ansätze. Das ermöglicht frühere Feedbackzyklen, weniger Beanstandungen in späten Phasen, reibungslosere Einreichungen bei den Behörden und letztlich kürzere Entwicklungszyklen sowie eine schnellere Markteinführung.\u003C\u002Fp>","content_list","Schneller und planbarer zur Compliance",{"id":305,"icon":225,"link":225,"logo":225,"media":225,"text":306,"title":308},"35492",{"value":307,"processed":307,"format":302},"\u003Cp>Indem Abhängigkeiten und Risikotreiber früh sichtbar werden, lassen sich späte Designänderungen und Korrekturmaßnahmen deutlich reduzieren. 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Trotzdem behandeln viele Unternehmen Risikomanagement noch immer als nachgelagerte, dokumentenlastige Aufgabe, losgelöst von den zentralen Engineering- und Designentscheidungen. Das führt häufig zu Nacharbeiten, verzögerten Einreichungen und vermeidbaren regulatorischen Beanstandungen spät im Entwicklungszyklus.\u003C\u002Fp>\u003Cp>Die Partnerschaft von Reshape und Zühlke steht für eine gemeinsame Überzeugung: Wer in der Medizintechnik schneller compliant werden, Risiken senken und die F&E-Produktivität steigern will, braucht spezialisierte, problemspezifische KI. Diese muss tief in reale Entwicklungs- und Qualitätsabläufe integriert und eng mit der Umsetzung im Engineering verzahnt sein, um Risiken in komplexen F&E-Programmen früh zu reduzieren.\u003C\u002Fp>",{"__typename":288,"id":349,"ctaLink":225,"pgSharedText":350,"pgSharedTitle":352,"pgSharedCtaLink":225},"35496",{"value":351,"processed":351,"format":292},"\u003Cp>Reshape Systems ist ein Schweizer KI-Unternehmen, das nachvollziehbare, KI-gestützte Software für die Risikoanalyse komplexer technischer Systeme entwickelt. 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