Technical File Gap Analysis
Stop Guessing. Know Exactly What Your Technical File is Missing for Korea.
The "Translate and Submit" trap leads to massive delays.
MFDS interprets electrical safety, biocompatibility, cybersecurity, and software validation differently from CE / 510(k). An unoptimized file guarantees a deficiency letter and 6–9 months of delay.
STED Conversion Readiness
How cleanly your data maps to Korean Technical Documentation format.
Test Report Validation
Testing data (EMC, safety, biocomp, cyber) — what's accepted vs re-tested.
Clinical & Performance Scrutiny
Clinical and bench performance against Korean efficacy thresholds.
The Gap Analysis & Action Plan
An engineering-level report outlining exactly what's missing and how to fix it—before you officially submit.
Audit
Action plan
Proven Clarity Across Modalities.
FAQ (Frequently Asked Questions)
Common questions about Technical File Gap Analysis
Submit with absolute confidence.
When the authority issues a deficiency letter, you typically have limited time to respond. Avoid the panic of scrambling for data or rushing local testing. By identifying the gaps upfront, you control the timeline, optimize your R&D resources, and ensure a smooth, predictable clearance process.
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