redpoint
Key features
Requirements & Risk Analysis
User Needs, Design Requirements, Task Analysis, Hazard Analysis, FMECA, Verification & Validation.
Linking and tracing
End-to-end traceability from User Needs all the way through V&V testing.
AI collaboration
Let AI review your work and propose user needs, design requirements and hazards. Use AI to search for missing links.
Share with your team
Real-time multi-user editing or view only access.
Reporting & PDF export
Requirement and trace analytics, full PDF and CSV exports.
ISO 14971 / FDA ready
Structured to meet the needs of ISO 14971 and FDA 21 CFR 820.30.
Human Factors / Usability (URRA)
Task Analysis and Use-Related Risk Analysis. Ensure the user is at the center of you design and potential issues are mitigated from the beginning.
Import Normative Standards
Drop in a PDF and instantly build a set of requirements that you can link to and trace through verification.
Analyze FDA Recalls
Pull real-world FDA recalls for your device class and turn hard lessons into mitigations.
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.
Study the Accidents, So You Don't Become One
Medical device engineers, like climbers, must study the problems of the past to build the safest, most effective products for the future. FDA recall analysis belongs at the start of design - not the end.