Complete Software Traceability
End-to-end mapping from Software Requirements Specification (SRS) to unit/system test execution.
Audit-Ready Medical Device Software Validation (IEC 62304 & FDA 21 CFR Part 11)
Streamline your SaMD & AI medical device software compliance. Clear the FDA 510(k) and CE Mark hurdles with full traceability, risk management (ISO 14971), and automated testing protocols.
Why Vectors
Compliance engineered into every test cycle
AI/ML Compliance (FDA Good Machine Learning Practice)
Specialized validation protocols for adaptive and fixed medical AI models.
ISO 14971 Risk Integration
Automated hazard logs linked directly to software safety classifications (Class A, B, C).
Deliverables
What lands in your audit file
- Software Verification & Validation (V&V) Plan
- Software Architectural & Detailed Design Docs
- Traceability Matrix (SRS ↔ SDS ↔ Verification)
- Cybersecurity & HIPAA/GDPR Compliance Verification
Next step