redpointredpoint

Medical Device Development
Requirements & Traceability

Flawless execution when safety is on the line.

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Key features

Requirements & document types

User needs, task analysis, hazard analysis, FMECA, design requirements, verification & validation.

Linking and tracing

End-to-end traceability from user needs all the way to V&V evidence.

AI inspiration

Propose user needs, design requirements and hazards with built-in AI.

Share & collaborate

Real-time multi-user editing with role-based permissions.

Reporting & PDF export

Requirement and trace analytics, full PDF exports.

ISO 14971 / FDA ready

Structured to meet the needs of ISO 14971 and FDA 21 CFR 820.30.

Plans

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"Simple and powerful."