Medical Devices Standards & Lifecycle QC Suite
Medical Devices package for ISO 13485, ISO 14971, IEC 62304, cybersecurity, usability, biocompatibility, sterilization, EMC and UDI/labeling.
121 Utilities
FUZKK utility packages
medical-devices ISO13485 ISO14971 IEC62304 CSV→JSON LabWare
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 Devices Standards & Lifecycle QC Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| AcceptanceActivityChecker | Acceptance Activity Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| AlarmSystemRequirementChecker | Alarm System Requirement Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| AuthenticationAuthorizationControlChecker | Authentication Authorization Control Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| BatterySafetyRequirementChecker | Battery Safety Requirement Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| BenefitRiskAssessmentChecker | Benefit Risk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| BioburdenTrendChecker | Bioburden Trend Checker | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet, Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | Vet veterinary veterinary vaccines animal health | |
| BiocompatibilityGapAssessmentChecker | Biocompatibility Gap Assessment Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| BiologicalEvaluationPlanChecker | Biological Evaluation Plan Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| 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 | |
| CAPATrendChecker | CAPATrend Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| ChemicalCharacterizationCoverageChecker | Chemical Characterization Coverage Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ClaimsRiskConsistencyChecker | Claims Risk Consistency Checker | Medical Devices / UDILabeling 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 | |
| CodeReviewCoverageChecker | Code Review Coverage Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ComplaintHandlingChecker | Complaint Handling Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| ConfigurationBaselineChecker | Configuration Baseline Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CriticalTaskAnalysisChecker | Critical Task Analysis Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CybersecurityReleaseReadinessChecker | Cybersecurity Release Readiness Checker | Medical Devices / CybersecurityForMedicalDevices 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 | |
| CybersecurityThreatModelChecker | Cybersecurity Threat Model Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| CytotoxicityRequirementChecker | Cytotoxicity Requirement Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DataIntegritySecurityChecker | Data Integrity Security Checker | Medical Devices / CybersecurityForMedicalDevices 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 | |
| DesignControlComplianceChecker | Design Control Compliance Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| DeviceContactCategoryChecker | Device Contact Category Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DeviceHistoryRecordChecker | Device History Record Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| DeviceMasterRecordChecker | Device Master Record Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| ElectricalSafetyTestSummaryChecker | Electrical Safety Test Summary Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| EMCTestCoverageChecker | EMCTest Coverage Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| EnvironmentalMonitoringTrendChecker | Environmental Monitoring Trend Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| EOResidualsLimitChecker | EOResiduals Limit Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| EssentialPerformanceTraceabilityChecker | Essential Performance Traceability Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ExtractablesLeachablesRiskChecker | Extractables Leachables Risk Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| FormativeEvaluationCoverageChecker | Formative Evaluation Coverage Checker | Medical Devices / UsabilityEngineering 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 | |
| IFULabelingUsabilityChecker | IFULabeling Usability Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| IFURevisionConsistencyChecker | IFURevision Consistency Checker | Medical Devices / UDILabeling 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 | |
| InitialRiskEvaluator | Initial Risk Evaluator | Medical Devices / MedicalDeviceRiskManagement 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 | |
| InternalAuditFindingTrendChecker | Internal Audit Finding Trend Checker | Medical Devices / MedicalDeviceQMS Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| LeakageCurrentResultChecker | Leakage Current Result Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| MDRReadinessChecker | MDRReadiness Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| MultilingualLabelCompletenessChecker | Multilingual Label Completeness Checker | Medical Devices / UDILabeling 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 | |
| OverallResidualRiskChecker | Overall Residual Risk Checker | Medical Devices / MedicalDeviceRiskManagement Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| PackagingIntegrityChecker | Packaging Integrity Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| PackagingLabelTraceabilityChecker | Packaging Label Traceability Checker | Medical Devices / UDILabeling Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| PatchImpactAssessmentChecker | Patch Impact Assessment Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ProcessValidationChecker | Process Validation Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| ProductionRecordConsistencyChecker | Production Record Consistency Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ProgrammableElectricalMedicalSystemChecker | Programmable Electrical Medical System Checker | Medical Devices / ElectricalSafetyEMC Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| PurchasingControlChecker | Purchasing Control Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| QualitySystemRecordChecker | Quality System Record Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| RadiationDoseAuditChecker | Radiation Dose Audit Checker | Medical Devices / SterileMedicalDevices 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 | |
| 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 | |
| RiskControlForElectricalHazardsChecker | Risk Control For Electrical Hazards Checker | Medical Devices / ElectricalSafetyEMC 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 | |
| RiskRequirementTraceabilityChecker | Risk Requirement Traceability Checker | Medical Devices / MedicalDeviceSoftware Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SBOMCompletenessChecker | SBOMCompleteness Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SecureConfigurationChecker | Secure Configuration Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SecurityAnomalyTrendChecker | Security Anomaly Trend Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SecurityRiskControlTraceabilityChecker | Security Risk Control Traceability Checker | Medical Devices / CybersecurityForMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SensitizationIrritationRequirementChecker | Sensitization Irritation Requirement Checker | Medical Devices / Biocompatibility Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| ShelfLifeStabilityChecker | Shelf Life Stability Checker | Medical Devices / SterileMedicalDevices 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 | |
| SOUPRiskAssessmentChecker | SOUPRisk Assessment Checker | Medical Devices / MedicalDeviceRiskManagement 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 | |
| StatisticalProcessControlChecker | Statistical Process Control Checker | Medical Devices / FDAMedicalDeviceCompliance Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SteamSterilizationValidationChecker | Steam Sterilization Validation Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SterilityAssuranceLevelChecker | Sterility Assurance Level Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SterilizationCycleParameterChecker | Sterilization Cycle Parameter Checker | Medical Devices / SterileMedicalDevices Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| SummativeEvaluationReadinessChecker | Summative Evaluation Readiness Checker | Medical Devices / UsabilityEngineering 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 | |
| SymbolStandardUsageChecker | Symbol Standard Usage Checker | Medical Devices / UDILabeling 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 | |
| SystemicToxicityRequirementChecker | Systemic Toxicity Requirement Checker | Medical Devices / Biocompatibility 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 | |
| UDIBarcodeFormatChecker | UDIBarcode Format Checker | Medical Devices / UDILabeling Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UDIDataCompletenessChecker | UDIData Completeness Checker | Medical Devices / UDILabeling Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UDILabelingSuite_LabelingConsistencyChecker | UDILabeling Suite Labeling Consistency Checker | Medical Devices / UDILabeling 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 | |
| UsabilityValidationFindingChecker | Usability Validation Finding Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UseErrorHazardLinkageChecker | Use Error Hazard Linkage Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UseSpecificationCompletenessChecker | Use Specification Completeness Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| UserInterfaceRiskControlChecker | User Interface Risk Control Checker | Medical Devices / UsabilityEngineering Suite, medical-device, FUZKK backlog 2026 | CSV→JSON IEC62304 ISO13485 ISO14971 | |
| VulnerabilityTriageChecker | Vulnerability Triage Checker | Medical Devices / CybersecurityForMedicalDevices 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.