FDA Medical Device Compliance Suite
FDA Medical Device Compliance Suite: specialised Medical Devices standards/lifecycle utility subpackage.
12 Utilities
FUZKK utility packages
medical-devices CSV→JSON LabWare standards
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 → FDA Medical Device Compliance 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 | |
| CAPATrendChecker | CAPATrend Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| DesignControlComplianceChecker | Design Control Compliance Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| MDRReadinessChecker | MDRReadiness Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| ProductionRecordConsistencyChecker | Production Record Consistency Checker | Medical Devices / FDAMedicalDeviceCompliance 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 | |
| StatisticalProcessControlChecker | Statistical Process Control Checker | Medical Devices / FDAMedicalDeviceCompliance 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.