Links to eight full company maps and eight updated compact versions.
Eight fields are presented in two formats. The full map covers Product/API, Instrumental and Medical Devices; the Instrumental layer is split into Lumex and LabEx columns. The compact version retains the shorter original format.
| # | API / product | Utility | Key checks |
|---|---|---|---|
| 1 | Acceptance Activity Checker | acceptance activity checker | Acceptance Activity Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critic… |
| 2 | CAPATrend Checker | capatrend checker | CAPATrend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critical/major f… |
| 3 | Complaint Handling Checker | complaint handling checker | Complaint Handling Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critica… |
| 4 | Design Control Compliance Checker | design control compliance checker | Design Control Compliance Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open… |
| 5 | Device History Record Checker | device history record checker | Device History Record Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open crit… |
| 6 | Device Master Record Checker | device master record checker | Device Master Record Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open criti… |
| 7 | MDRReadiness Checker | mdrreadiness checker | MDRReadiness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critical/majo… |
| 8 | Process Validation Checker | process validation checker | Process Validation Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critica… |
| 9 | Production Record Consistency Checker | production record consistency checker | Production Record Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • o… |
| 10 | Purchasing Control Checker | purchasing control checker | Purchasing Control Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open critica… |
| 11 | Quality System Record Checker | quality system record checker | Quality System Record Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • open crit… |
| 12 | Statistical Process Control Checker | statistical process control checker | Statistical Process Control Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 04_FDAMedicalDeviceComplianceSuite: • compliance score • traceability coverage • ope… |
| 13 | Authentication Authorization Control Checker | authentication authorization control checker | Authentication Authorization Control Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability c… |
| 14 | Cybersecurity Release Readiness Checker | cybersecurity release readiness checker | Cybersecurity Release Readiness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability covera… |
| 15 | Cybersecurity Threat Model Checker | cybersecurity threat model checker | Cybersecurity Threat Model Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage •… |
| 16 | Data Integrity Security Checker | data integrity security checker | Data Integrity Security Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • ope… |
| 17 | Patch Impact Assessment Checker | patch impact assessment checker | Patch Impact Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • ope… |
| 18 | SBOMCompleteness Checker | sbomcompleteness checker | SBOMCompleteness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • open criti… |
| 19 | Secure Configuration Checker | secure configuration checker | Secure Configuration Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • open c… |
| 20 | Security Anomaly Trend Checker | security anomaly trend checker | Security Anomaly Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • open… |
| 21 | Security Risk Control Traceability Checker | security risk control traceability checker | Security Risk Control Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability cov… |
| 22 | Vulnerability Triage Checker | vulnerability triage checker | Vulnerability Triage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 05_CybersecurityForMedicalDevicesSuite: • compliance score • traceability coverage • open c… |
| 23 | Critical Task Analysis Checker | critical task analysis checker | Critical Task Analysis Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open critical/… |
| 24 | Formative Evaluation Coverage Checker | formative evaluation coverage checker | Formative Evaluation Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open cr… |
| 25 | IFULabeling Usability Checker | ifulabeling usability checker | IFULabeling Usability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open critical/m… |
| 26 | Summative Evaluation Readiness Checker | summative evaluation readiness checker | Summative Evaluation Readiness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open c… |
| 27 | Usability Validation Finding Checker | usability validation finding checker | Usability Validation Finding Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open cri… |
| 28 | Use Error Hazard Linkage Checker | use error hazard linkage checker | Use Error Hazard Linkage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open critica… |
| 29 | User Interface Risk Control Checker | user interface risk control checker | User Interface Risk Control Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open crit… |
| 30 | Use Specification Completeness Checker | use specification completeness checker | Use Specification Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 06_UsabilityEngineeringSuite: • compliance score • traceability coverage • open c… |
| 31 | Biocompatibility Gap Assessment Checker | biocompatibility gap assessment checker | Biocompatibility Gap Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open crit… |
| 32 | Biological Evaluation Plan Checker | biological evaluation plan checker | Biological Evaluation Plan Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open critical/… |
| 33 | Chemical Characterization Coverage Checker | chemical characterization coverage checker | Chemical Characterization Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open c… |
| 34 | Cytotoxicity Requirement Checker | cytotoxicity requirement checker | Cytotoxicity Requirement Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open critical/ma… |
| 35 | Device Contact Category Checker | device contact category checker | Device Contact Category Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open critical/maj… |
| 36 | Extractables Leachables Risk Checker | extractables leachables risk checker | Extractables Leachables Risk Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open critica… |
| 37 | Sensitization Irritation Requirement Checker | sensitization irritation requirement checker | Sensitization Irritation Requirement Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open… |
| 38 | Systemic Toxicity Requirement Checker | systemic toxicity requirement checker | Systemic Toxicity Requirement Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 07_BiocompatibilitySuite: • compliance score • traceability coverage • open critic… |
| 39 | Bioburden Trend Checker | bioburden trend checker | Bioburden Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/major… |
| 40 | Environmental Monitoring Trend Checker | environmental monitoring trend checker | Environmental Monitoring Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open… |
| 41 | EOResiduals Limit Checker | eoresiduals limit checker | EOResiduals Limit Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/majo… |
| 42 | Packaging Integrity Checker | packaging integrity checker | Packaging Integrity Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/ma… |
| 43 | Radiation Dose Audit Checker | radiation dose audit checker | Radiation Dose Audit Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/m… |
| 44 | Shelf Life Stability Checker | shelf life stability checker | Shelf Life Stability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/m… |
| 45 | Steam Sterilization Validation Checker | steam sterilization validation checker | Steam Sterilization Validation Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open… |
| 46 | Sterility Assurance Level Checker | sterility assurance level checker | Sterility Assurance Level Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open criti… |
| 47 | Sterilization Cycle Parameter Checker | sterilization cycle parameter checker | Sterilization Cycle Parameter Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open c… |
| 48 | Alarm System Requirement Checker | alarm system requirement checker | Alarm System Requirement Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • open critical… |
| 49 | Battery Safety Requirement Checker | battery safety requirement checker | Battery Safety Requirement Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • open critic… |
| 50 | Electrical Safety Test Summary Checker | electrical safety test summary checker | Electrical Safety Test Summary Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • open cr… |
| 51 | EMCTest Coverage Checker | emctest coverage checker | EMCTest Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • open critical/major f… |
| 52 | Essential Performance Traceability Checker | essential performance traceability checker | Essential Performance Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • ope… |
| 53 | Leakage Current Result Checker | leakage current result checker | Leakage Current Result Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • open critical/m… |
| 54 | Programmable Electrical Medical System Checker | programmable electrical medical system checker | Programmable Electrical Medical System Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage •… |
| 55 | Risk Control For Electrical Hazards Checker | risk control for electrical hazards checker | Risk Control For Electrical Hazards Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 09_ElectricalSafetyEMCSuite: • compliance score • traceability coverage • op… |
| 56 | Claims Risk Consistency Checker | claims risk consistency checker | Claims Risk Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/major fi… |
| 57 | IFURevision Consistency Checker | ifurevision consistency checker | IFURevision Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/major fi… |
| 58 | Multilingual Label Completeness Checker | multilingual label completeness checker | Multilingual Label Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/… |
| 59 | Packaging Label Traceability Checker | packaging label traceability checker | Packaging Label Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/maj… |
| 60 | Symbol Standard Usage Checker | symbol standard usage checker | Symbol Standard Usage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/major find… |
| 61 | UDIBarcode Format Checker | udibarcode format checker | UDIBarcode Format Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/major findings… |
| 62 | UDIData Completeness Checker | udidata completeness checker | UDIData Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open critical/major findi… |
| 63 | UDILabeling Suite Labeling Consistency Checker | udilabeling suite labeling consistency checker | UDILabeling Suite_Labeling Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 10_UDILabelingSuite: • compliance score • traceability coverage • open cr… |
| 64 | Benefit Risk Assessment Checker | benefit risk assessment checker | Benefit Risk Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open c… |
| 65 | Clinical Risk Assessment Checker | clinical risk assessment checker | Clinical Risk Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open… |
| 66 | Cybersecurity Risk Assessment Checker | cybersecurity risk assessment checker | Cybersecurity Risk Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage •… |
| 67 | Hazard Analysis Quality Checker | hazard analysis | Hazard Analysis Quality Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open c… |
| 68 | Hazard Identification Completeness Checker | hazard identification completeness checker | Hazard Identification Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability covera… |
| 69 | Hazardous Situation Linkage Checker | hazardous situation linkage checker | Hazardous Situation Linkage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • op… |
| 70 | Initial Risk Evaluator | initial risk evaluator | Initial Risk Evaluator — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open critical/m… |
| 71 | Overall Residual Risk Checker | overall residual risk checker | Overall Residual Risk Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open cri… |
| 72 | Production Post Production Risk Trend Checker | production post production risk trend checker | Production Post Production Risk Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability cov… |
| 73 | Residual Risk Disclosure Checker | residual risk disclosure checker | Residual Risk Disclosure Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open… |
| 74 | Residual Risk Evaluator | residual risk evaluator | Residual Risk Evaluator — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open critical/… |
| 75 | Risk Acceptability Checker | risk acceptability checker | Risk Acceptability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open critic… |
| 76 | Risk Control Option Analysis Checker | risk control option analysis checker | Risk Control Option Analysis Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • o… |
| 77 | Risk Control Traceability Checker | risk control traceability checker | Risk Control Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open… |
| 78 | Risk Control Verification Checker | risk control verification checker | Risk Control Verification Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open… |
| 79 | Risk Management File Index Checker | risk management file index checker | Risk Management File Index Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • ope… |
| 80 | Risk Management Report Completeness Checker | risk management report completeness checker | Risk Management Report Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability cover… |
| 81 | Risk Matrix Calculator | risk matrix calculator | Risk Matrix Calculator — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open critical/m… |
| 82 | Risk Reduction Effectiveness Checker | risk reduction effectiveness checker | Risk Reduction Effectiveness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • o… |
| 83 | SOUPRisk Assessment Checker | souprisk assessment checker | SOUPRisk Assessment Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 01_MedicalDeviceRiskManagementSuite: • compliance score • traceability coverage • open criti… |
| 84 | Calibration Schedule Checker | calibration schedule checker | Calibration Schedule Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major… |
| 85 | Calibration Status Checker | calibration status checker | Calibration Status Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major fi… |
| 86 | CAPAEffectiveness Checker | capaeffectiveness checker | CAPAEffectiveness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major fin… |
| 87 | Change Control Impact Checker | change control impact checker | Change Control Impact Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major… |
| 88 | Complaint Trend Checker | complaint trend checker | Complaint Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major findi… |
| 89 | Design Input Completeness Checker | design input completeness checker | Design Input Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/m… |
| 90 | Design Output Consistency Checker | design output consistency checker | Design Output Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/m… |
| 91 | Design Review Checklist Checker | design review checklist checker | Design Review Checklist Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/maj… |
| 92 | Design Validation Coverage Checker | design validation coverage checker | Design Validation Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/… |
| 93 | Design Verification Coverage Checker | design verification coverage checker | Design Verification Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critica… |
| 94 | DHFCompleteness Checker | dhfcompleteness checker | DHFCompleteness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major findi… |
| 95 | DHRCompleteness Checker | dhrcompleteness checker | DHRCompleteness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major findi… |
| 96 | DMRCompleteness Checker | dmrcompleteness checker | DMRCompleteness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major findi… |
| 97 | Incoming Inspection Sampling Checker | incoming inspection sampling checker | Incoming Inspection Sampling Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critica… |
| 98 | Internal Audit Finding Trend Checker | internal audit finding trend checker | Internal Audit Finding Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critica… |
| 99 | Medical Device QMSSuite Labeling Consistency Checker | medical device qmssuite labeling consistency checker | Medical Device QMSSuite_Labeling Consistency Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverag… |
| 100 | Nonconformity Trend Checker | nonconformity trend checker | Nonconformity Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major f… |
| 101 | Supplier Evaluation Checker | supplier evaluation checker | Supplier Evaluation Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major f… |
| 102 | Traceability Matrix Checker | traceability matrix checker | Traceability Matrix Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/major f… |
| 103 | Training Matrix Compliance Checker | training matrix compliance checker | Training Matrix Compliance Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 02_MedicalDeviceQMSSuite: • compliance score • traceability coverage • open critical/… |
| 104 | Code Review Coverage Checker | code review coverage checker | Code Review Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/m… |
| 105 | Configuration Baseline Checker | configuration baseline checker | Configuration Baseline Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical… |
| 106 | Defect Trend Checker | defect trend checker | Defect Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/major fin… |
| 107 | Integration Test Coverage Checker | integration test coverage checker | Integration Test Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open criti… |
| 108 | Regression Test Completeness Checker | regression test completeness checker | Regression Test Completeness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open cr… |
| 109 | Release Readiness Checker | release readiness checker | Release Readiness Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/majo… |
| 110 | Requirement Traceability Checker | requirement traceability checker | Requirement Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critic… |
| 111 | Risk Requirement Traceability Checker | risk requirement traceability checker | Risk Requirement Traceability Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open c… |
| 112 | Software Architecture Risk Checker | software architecture risk checker | Software Architecture Risk Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open crit… |
| 113 | Software Build Reproducibility Checker | software build reproducibility checker | Software Build Reproducibility Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open… |
| 114 | Software Maintenance Impact Checker | software maintenance impact checker | Software Maintenance Impact Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open cri… |
| 115 | Software Problem Resolution Checker | software problem resolution checker | Software Problem Resolution Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open cri… |
| 116 | Software Safety Class Checker | software safety class checker | Software Safety Class Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/… |
| 117 | SOUPInventory Checker | soupinventory checker | SOUPInventory Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/major fi… |
| 118 | SOUPVersion Checker | soupversion checker | SOUPVersion Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/major find… |
| 119 | Static Analysis Summary Checker | static analysis summary checker | Static Analysis Summary Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critica… |
| 120 | System Test Coverage Checker | system test coverage checker | System Test Coverage Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 03_MedicalDeviceSoftwareSuite: • compliance score • traceability coverage • open critical/m… |