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The platform models medical device systems and their interdependencies using structured, explainable representations, enabling teams to identify critical risks early, understand how failures propagate across the system, and reason about design trade-offs before key decisions are locked in.\u003C\u002Fp>","full_html",{"__typename":290,"id":291,"columns":292,"listItems":293,"text":310,"title":311,"variant":312},"ParagraphPgContentList","35494","3col",[294,300,305],{"id":295,"icon":221,"link":221,"logo":221,"media":221,"text":296,"title":299},"35491",{"value":297,"processed":297,"format":298},"\u003Cp>Continuous, system-level risk analysis aligned with ISO 14971 can be performed up to 10× faster than traditional document-based approaches, enabling earlier feedback cycles, fewer late-stage findings, smoother regulatory submissions, and ultimately shorter development cycles and faster time to market.\u003C\u002Fp>","content_list","Faster and more predictable time to compliance",{"id":301,"icon":221,"link":221,"logo":221,"media":221,"text":302,"title":304},"35492",{"value":303,"processed":303,"format":298},"\u003Cp>By exposing interdependencies and risk drivers early, organizations can significantly reduce late design changes and corrective actions. In risk-intensive phases, this can translate into up to 80% reduction in engineering effort related to risk mitigation, rework, and corrective loops.\u003C\u002Fp>","Reduced technical and regulatory risk",{"id":306,"icon":221,"link":221,"logo":221,"media":221,"text":307,"title":309},"35493",{"value":308,"processed":308,"format":298},"\u003Cp>Engineers spend less time maintaining fragmented risk documentation and responding to downstream issues, and more time making informed, traceable design decisions supported by continuously updated risk models, resulting in more predictable R&D execution and improved resource efficiency.\u003C\u002Fp>","Higher R&D productivity and decision quality","For MedTech R&D organizations, the joint solution is supposed to deliver three tangible benefits: ","Benefits for MedTech R&D","default",{"__typename":252,"id":314,"eyebrow":221,"pgQuoteRefQuote":315,"hideImage":257,"hideFunctionAndCompany":257,"bigQuote":257},"35499",[316],{"status":7,"id":317,"promote":257,"quotePersonDesc":318,"quotePersonName":319,"quoteText":320,"profileImage":321,"title":339},"27113","CEO Reshape Systems","Andrea Apollonio","Our goal is to support engineers with AI that enhances expert judgement through transparent, auditable reasoning. 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Yet risk management is still often treated as a late-stage, documentation-heavy activity, disconnected from core engineering and design decisions. This frequently leads to rework, delayed submissions, and avoidable regulatory findings late in the development lifecycle.\u003C\u002Fp>\u003Cp>The partnership between Reshape and Zühlke reflects a shared conviction that accelerating time to compliance, reducing risk, and increasing R&D productivity in MedTech requires vertical, problem-specific AI, deeply integrated into real development and quality workflows, and tightly coupled with engineering execution to de-risk complex R&D programs.\u003C\u002Fp>",{"__typename":284,"id":345,"ctaLink":221,"pgSharedText":346,"pgSharedTitle":348,"pgSharedCtaLink":221},"35496",{"value":347,"processed":347,"format":288},"\u003Cp>Reshape Systems is a Swiss AI company that builds explainable, AI-driven risk analysis software for complex engineered systems. 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