Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Пакет содержит автономные CSV→JSON QC-утилиты FUZKK. Каждая утилита имеет встроенное самоописание, пример input.csv, demo-evaluation и LabWare-compatible JSON output.
⏱ Время лаборатории
Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.
🚀 Интеграция
Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.
Схема интеграции
Instrument / LIMS / ELN / MES → input.csv → Medical Device Risk Management → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| 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 |
Лицензирование и поддержка
Поставка as-is на юридическое лицо без права перепродажи. Валидация, CSV/URS/FS review и внедрение в LIMS выполняются на стороне заказчика или отдельным проектом.