Bringing a medical device to market means managing rigorous requirements across hardware, software, and clinical domains—while staying compliant with standards like ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820. But in practice, requirements live in fragmented tools. Traceability is incomplete. Risk management is disconnected from product architecture.

And every change—big or small—can cascade into time-consuming rework and review cycles. Trace.Space brings structure, speed, and clarity to medical development. Our AI-native platform helps medtech teams:

• Unify requirements, design, and risk management in a single traceable system.
• Automatically maintain trace links between user needs, hazards, software units, and test cases.
• Support faster design iterations while maintaining full compliance readiness.
• Integrate with QMS and verification tools through modern, flexible APIs.
• Scale easily as teams and product portfolios grow—without adding process drag.

With Trace.Space, medical device teams can move fast without cutting corners—confident that every decision is traceable, review-ready, and built for compliance from day one.