Cybersecurity
MFDS Cybersecurity Submission Package — Compiled From Your Existing Evidence.
MFDS expects a Korean-specific cybersecurity submission — not your FDA 524B or EU MDR file.
MFDS-aligned submission package compiled from your existing threat model, SBOM, and verification evidence — tailored to on-premise or cloud-connected deployment. Threat modeling, pen-testing, and multi-jurisdiction harmonization are out of scope.
MFDS Submission Package Compilation
We translate your existing cybersecurity evidence into the MFDS-required document set in Korean: Cybersecurity Risk Management Report, SBOM rendered in MFDS submission format, and Verification & Validation summary.
On-Premise & Cloud Variants
Package scope adjusts to your deployment model. On-premise devices require a narrower risk profile; cloud-connected systems require additional documentation covering hosting boundaries, data flows, and cloud-specific incident response.
Post-Market Cybersecurity Plan
We author the Post-Market Cybersecurity Management Plan and cybersecurity labeling/IFU statements MFDS requires for licensed devices — keeping the submission valid through post-market scrutiny.
The MFDS Cybersecurity Submission Package
Korean-language documentation set compiled from your existing threat model, SBOM, and verification evidence — ready for MFDS review.
MFDS submission packages, built from manufacturer-supplied evidence.
Frequently Asked Questions
Common questions about the MFDS cybersecurity submission package.
Bring us your threat model, SBOM, and verification results — we compile the rest.
Fixed-fee package, scoped in writing after a 30-minute discovery call. On-premise and cloud-connected variants quoted separately.
Request a Cybersecurity Scope