Korea Audit Readiness
MFDS Audits Arrive in 30–60 Days. Your Compliance Gaps Take Longer to Fix.
When Korea Audit Readiness Is the Right Fit.
Three scenarios where an MFDS audit demands a structured gap review.
MFDS Audit Notification Received
Formal MFDS notice in hand, 30–60 days out — prioritized gap review and remediation executed in window.
Pre-Scheduled Surveillance Inspection
Routine MFDS surveillance ahead — proactive review to confirm compliance and close latent gaps first.
Post-Failure Remediation Audit
Prior MFDS inspection returned non-conformances — structured remediation closing flagged gaps before follow-up.
Every Deliverable Required to Pass an MFDS Audit.
Three coordinated services producing a defensible audit-readiness record.
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KGMP QMS Gap Report
Written assessment of QMS records, SOPs, and evidence against the KGMP criteria MFDS inspectors apply.
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Technical File Gap Report
Registered technical files assessed against current MFDS STED — flagging outdated, incomplete, or inconsistent content.
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Risk-Prioritized Gap List
Consolidated gap list ranked by inspection probability — concentrating effort on highest-risk findings, not evenly across all gaps.
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Remediation Action Plan
Sequenced remediation plan with owners, deliverables, and close dates aligned to the inspection date.
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Pre-Inspection Mock Review
Mock review applying MFDS inspector criteria to remediated records — confirming closure before the actual audit.
MFDS Inspections Passed for Manufacturers Across Multiple Device Categories.
45-Day Audit Preparation for a Manufacturer With Multiple Compliance Gaps
Pre-Scheduled Surveillance Inspection Readiness for a European Portfolio
Frequently Asked Questions
Common questions answered.
An Audit Readiness Report and a Remediation-Prioritized Preparation Plan.
A gap we identify is one you can close before it becomes a finding — reviewed under the same criteria MFDS inspectors apply.
Speak with an Audit Readiness Specialist Today