Why FUZKK utilities
✓ Fewer Excel risks
Deterministic calculation and rule checks instead of uncontrolled spreadsheets.
🔍 Audit readiness
The package contains standalone FUZKK CSV-to-JSON QC utilities. Each utility includes built-in self-documentation, an input.csv example, demo evaluation and LabWare-compatible JSON output.
⏱ Laboratory time
Faster data checks, batch review and structured JSON output for downstream systems.
🚀 Integration
Designed for CSV, LIMS/ELN/MES and validated laboratory workflows.
Integration workflow
Instrument / LIMS / ELN / MES → input.csv → Medical Device Software Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| CodeReviewCoverageChecker | Code Review Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ConfigurationBaselineChecker | Configuration Baseline Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DefectTrendChecker | Defect Trend Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| IntegrationTestCoverageChecker | Integration Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RegressionTestCompletenessChecker | Regression Test Completeness Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ReleaseReadinessChecker | Release Readiness Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RequirementTraceabilityChecker | Requirement Traceability Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskRequirementTraceabilityChecker | Risk Requirement Traceability Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareArchitectureRiskChecker | Software Architecture Risk Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareBuildReproducibilityChecker | Software Build Reproducibility Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareMaintenanceImpactChecker | Software Maintenance Impact Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareProblemResolutionChecker | Software Problem Resolution Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SoftwareSafetyClassChecker | Software Safety Class Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SOUPInventoryChecker | SOUPInventory Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SOUPVersionChecker | SOUPVersion Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| StaticAnalysisSummaryChecker | Static Analysis Summary Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SystemTestCoverageChecker | System Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UnitTestCoverageChecker | Unit Test Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 |
Licensing and support
Supplied as-is to a legal entity without resale rights. Validation, CSV/URS/FS review and LIMS implementation are performed by the customer or as a separate project.