Documentation Readiness
How cleanly your existing DHF, technical file, test evidence, and claims map to the target submission structure.
Technical File Gap Analysis
Know what your technical file is missing before submission.
A weak technical file turns review into remediation.
Test Report Validation
Whether safety, EMC, biocompatibility, software, cybersecurity, and usability evidence is current, complete, and usable.
Clinical & Performance Scrutiny
Whether clinical, bench, and performance data can support the intended use, indications, and market-facing claims.
Service specification
Korea Technical File Gap Analysis
You know what will be reviewed, what is excluded, what you receive, what your team must provide, and how remediation is scoped after the analysis.
Request assessmentFor Korea, the review maps your existing file to Korea-specific technical documentation, MFDS or designated review expectations, KGMP submission-file dependencies, cybersecurity and usability expectations, and Korean-language filing needs.
Document structure, evidence completeness, report validity, claims support; Full document rewrite, testing execution, authority filing
Gap matrix with severity, rationale, owner, and recommended action; Working session to confirm remediation priorities
Typically 2–4 weeks after complete document intake; Kickoff, intake check, technical review, gap report, review meeting
DHF or technical file, IFU, claims, test reports, clinical summaries; SME access for file context and remediation decisions
Fixed-fee when file scope is clear; Remediation and submission work scoped separately
Application patterns across file types.
AI Diagnostic Software
Mapped software, cybersecurity, validation, and clinical-evidence gaps before submission planning.
Wellness vs. Medical Device
Reviewed claim language and evidence gaps for a borderline light-therapy device.
High-Risk Implant File
Identified clinical, bench, and risk-management gaps in a high-risk implant file.
FAQ (Frequently Asked Questions)
Common questions about Technical File Gap Analysis