The platform connecting software requirements directly to risk analysis. Built for SaMD teams, Class II/III devices, and everything in between.
Admin functions, data display
Monitoring, alerting
Infusion pumps, AI diagnostics
Track via custom fields today. Auto-inheritance coming Q1 2025.
Honest about what's ready, what's partial, and what's coming
User needs → Design input → Implementation → Verification
Hazard identification, risk estimation, and control measures
Complete change history with timestamps and user tracking
Role-based permissions with organization isolation
Class A/B/C tracking via custom fields (auto-inheritance on roadmap)
Electronic signatures for approvals and reviews
NirmIQ provides audit trails, access controls, and traceability features. However, we do not yet have 21 CFR Part 11 compliant electronic signatures. E-signatures are on our Q1 2025 roadmap. If your workflows require Part 11 e-signatures today, please discuss your timeline with us.
The fundamentals medical device teams need
Connect every software requirement to its associated hazard analysis. When requirements change, see affected risk controls immediately.
Trace from user needs through design inputs, implementation, and verification. Full visibility for design reviews and audits.
Every change tracked with who, what, when, and why. 7-year retention for regulatory evidence.
Document failure modes, effects, and controls. Track Risk Priority Numbers over time as mitigations are implemented.
Every requirement links to its associated hazards, risk controls, and residual risk assessment
Link hazards to software requirements that could cause them
Document control measures and trace to implementation
Track residual risk and benefit-risk analysis
Start with traceability and FMEA today. We'll grow with you as regulatory needs evolve.