MedTech
Zühlke and Reshape Systems partner to accelerate time to compliance in MedTech R&D
“Risk analysis in MedTech must be rigorous, explainable, and compliant. By embedding ISO 14971-aligned, explainable AI-driven risk analysis directly into R&D workflows, we help organisations reduce risk while accelerating time to compliance.”
At the core of the collaboration is the integration of Reshape’s graph-based, explanable AI risk analysis platform into MedTech development processes. 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.
Benefits for MedTech R&D
For MedTech R&D organizations, the joint solution is supposed to deliver three tangible benefits:
Faster and more predictable time to compliance
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.
Reduced technical and regulatory risk
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.
Higher R&D productivity and decision quality
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.
“Our goal is to support engineers with AI that enhances expert judgement through transparent, auditable reasoning. By making system-level risks explicit and continuously updated, teams can make better decisions earlier and avoid costly late-stage surprises.”
Medical device development operates under strict regulatory and safety requirements while system complexity and development speed continue to increase. 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.
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.
About Reshape Systems
Reshape Systems is a Swiss AI company that builds explainable, AI-driven risk analysis software for complex engineered systems. A spin-off of CERN, it draws on more than a decade of experience safeguarding particle accelerators to help engineering teams identify failures early and make better design decisions across safety-critical industries.
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