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 QMS Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| CalibrationScheduleChecker | Calibration Schedule Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CalibrationStatusChecker | Calibration Status Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CAPAEffectivenessChecker | CAPAEffectiveness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ChangeControlImpactChecker | Change Control Impact Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ComplaintTrendChecker | Complaint Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignInputCompletenessChecker | Design Input Completeness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignOutputConsistencyChecker | Design Output Consistency Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignReviewChecklistChecker | Design Review Checklist Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignValidationCoverageChecker | Design Validation Coverage Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DesignVerificationCoverageChecker | Design Verification Coverage Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DHFCompletenessChecker | DHFCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DHRCompletenessChecker | DHRCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DMRCompletenessChecker | DMRCompleteness Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| IncomingInspectionSamplingChecker | Incoming Inspection Sampling Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| InternalAuditFindingTrendChecker | Internal Audit Finding Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| MedicalDeviceQMSSuite_LabelingConsistencyChecker | Medical Device QMSSuite Labeling Consistency Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| NonconformityTrendChecker | Nonconformity Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SupplierEvaluationChecker | Supplier Evaluation Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| TraceabilityMatrixChecker | Traceability Matrix Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| TrainingMatrixComplianceChecker | Training Matrix Compliance Checker | Medical Devices / MedicalDeviceQMS 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.