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 Risk Management Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| BenefitRiskAssessmentChecker | Benefit Risk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ClinicalRiskAssessmentChecker | Clinical Risk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CybersecurityRiskAssessmentChecker | Cybersecurity Risk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| HazardAnalysisQualityChecker | Hazard Analysis Quality Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| HazardIdentificationCompletenessChecker | Hazard Identification Completeness Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| HazardousSituationLinkageChecker | Hazardous Situation Linkage Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| InitialRiskEvaluator | Initial Risk Evaluator | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| OverallResidualRiskChecker | Overall Residual Risk Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ProductionPostProductionRiskTrendChecker | Production Post Production Risk Trend Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ResidualRiskDisclosureChecker | Residual Risk Disclosure Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ResidualRiskEvaluator | Residual Risk Evaluator | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskAcceptabilityChecker | Risk Acceptability Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskControlOptionAnalysisChecker | Risk Control Option Analysis Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskControlTraceabilityChecker | Risk Control Traceability Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskControlVerificationChecker | Risk Control Verification Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskManagementFileIndexChecker | Risk Management File Index Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskManagementReportCompletenessChecker | Risk Management Report Completeness Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskMatrixCalculator | Risk Matrix Calculator | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RiskReductionEffectivenessChecker | Risk Reduction Effectiveness Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SOUPRiskAssessmentChecker | SOUPRisk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement 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.