510(k) Submission Packaging
Comprehensive FDA 510(k) submission package builder with complete structure, QA reports, readiness checks, and eSTAR mapping. Generates submission-ready packages with all required documents properly organized and formatted for FDA submission.
Complete structure. QA validated. Submission-ready.
Complete Package Structure
Comprehensive 9-folder structure with all required documents, metadata, and QA reports organized for FDA submission.
00_README
Documentation files, package overview, and submission instructions.
01_Metadata
Citation catalog, project metadata, and comprehensive bundle information.
02_Administrative
FDA Forms 3514, 3881, application info, contacts, and administrative documents.
03_Device
Device description, intended use, classification, and device-specific documentation.
04_Performance_Evidence
All test reports, performance data, bench testing, and evidence documentation.
05_Regulatory_Fit
Regulatory assessment, special controls mapping, and compliance documentation.
06_eSTAR_Mapping
eSTAR section mapping, catalog references, and structured submission data.
07_Submission_Ready
Master compilation, final documents, and submission-ready package.
08_QA_Reports
Readiness summary, quality assurance reports, and validation checks.
09_Legal
Legal documents, ownership rights, and compliance statements.
Advanced Capabilities
Comprehensive package building with exhaustive validation and quality assurance.
folder_managedComplete Organization
Automatically organizes all documents, evidence, forms, and supporting materials into the proper FDA submission structure.
check_circlePackaging Gate Service
Exhaustive readiness checks validate predicate selection, required forms, drafted sections, evidence coverage, and conditional modules before packaging.
ruleFDA Format Compliance
All documents formatted and structured according to FDA requirements. Proper file naming, organization, and eSTAR mapping included.
databaseComprehensive Bundle
Uses ComprehensiveBundle as single source of truth, aggregating all project data, assessments, evidence, and drafted content.
descriptioneSTAR Mapping
Complete eSTAR section mapping with catalog references, ensuring all required sections are properly mapped and included.
assessmentQA Reports
Comprehensive quality assurance reports including readiness summary, validation checks, and completeness assessment.
downloadSecure Download
Generate secure download URLs for complete submission packages. ZIP files with all documents properly organized and ready for FDA submission.
verifiedReadiness Validation
Validates all requirements are met before packaging: predicate selected, forms complete, sections drafted, evidence uploaded, and conditional modules addressed.
Why Choose Cruxi Packaging?
Comprehensive package building with exhaustive validation and quality assurance.
auto_awesomeIntelligent Aggregation
Automatically aggregates all project data from classification, assessment, predicate analysis, evidence, and drafted sections into a complete package.
shieldExhaustive Validation
Packaging gate service performs exhaustive checks on all requirements, ensuring nothing is missing before generating the final package.
speedOne-Click Generation
Generate complete submission packages with a single click. All documents organized, formatted, and ready for FDA submission.
verifiedSubmission-Ready
Every package is validated and ready for FDA submission. No manual organization or formatting required.
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Get complete submission packages with all documents organized and validated for FDA submission.
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