redpoint
Key features
Requirements & Risk Analysis
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. Use AI to search for missing links.
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
Frequently Asked Questions
Resources
Insights for Medical Device Teams
Medical Device Requirement Development & Traceability
Mastering the complex web of user needs, design requirements, verification and validation in modern medical device development.
Medical Device Risk Analysis
Risk analysis isn't a compliance check — it's a continuous engineering effort that shapes your device's safety and effectiveness from day one.
The Cost Benefit of Modern Purpose-Built Applications
Software is getting cheap. High-quality, purpose-built applications are more accessible than ever — and the astronomical cost of legacy systems is on its way out.
Design Traceability Matrix (DTM) Guide for Medical Devices
A practical guide to building a Design Traceability Matrix that satisfies FDA 21 CFR 820.30 and ISO 14971, linking user needs, design requirements, hazards, and V&V evidence.