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 → Biocompatibility Suite → output.json → QA approval / audit trail
Utilities in this package
| Utility | API / Monograph | Categories | Tags | |
|---|---|---|---|---|
| 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 | |
| ChemicalCharacterizationCoverageChecker | Chemical Characterization Coverage Checker | Medical Devices / Biocompatibility 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 | |
| DeviceContactCategoryChecker | Device Contact Category Checker | Medical Devices / Biocompatibility 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 | |
| SensitizationIrritationRequirementChecker | Sensitization Irritation Requirement Checker | Medical Devices / Biocompatibility 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 |
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.