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Korea · Safety Vigilance & Recall

Rapid-Response Medical Device Vigilance & Crisis Recall Operations

Full vigilance management securing statutory 7/15/30-day reporting deadlines, post-market safety and renewal safety dossiers, and recall crisis intervention.

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Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance

Formulated an emergency 7-day adverse event report and manufacturing RCA, securing clean closure with zero sanctions.

Active Devices · Robotics

IEC 60601-1 / 60601-1-2 (Ed. 4.1) · IEC 60601-2-XX Particular Standards

Essential Performance definition and worst-case test matrix optimization across accredited laboratories

Implants · Biomaterials

ISO 10993-1 to 23 Biocompatibility · ISO 11135 / 11137 Sterilization Validation

Biological endpoint matrix design and ISO 10993-18 chemical characterization / toxicological assessment

In Vitro Diagnostics (IVD)

Korea IVD Act & EU IVDR (2017/746) · CLSI EP Guidelines (EP05, EP06, EP12, EP17)

CLSI-compliant Limit of Detection (LoD), cross-reactivity, interference, and lot-to-lot reproducibility protocols

Proprietary Data & Precedent Validation

IMDRF Adverse Event Coding (Annex A–G) & Statutory Clock Triage

100% On-Time Statutory Reporting (7 / 15 / 30 Days) & IMDRF Nomenclature Mapping

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Event Triage to MFDS Filing & CAPA Closure

Step 01 / 04Stage Gate & Output

24-Hour Event Triage & Locked Statutory Reporting Clock

Incomplete baseline data or misclassified regulatory pathways are the primary drivers of multi-month submission delays. Gate 01 locks the device scope, predicate/standard mapping, and full document inventory before authoring begins.

Verification Baseline

Device description, intended use, existing test reports, and QMS document index

Gate Sign-Off Output

Confirmed classification matrix and locked submission master inventory

Agentic Automation & Platform Integration

Automated Statutory SLA Timers & Closed-Loop CAPA Integration

Automated 7 / 15 / 30-Day Statutory SLA Watchdogs

Trigger real-time countdown timers and escalation alerts the moment a potentially reportable event is logged.

Explore module

@CAPA— Run "Automated 7 / 15 / 30-Day Statutory SLA Watchdogs" across our Safety Vigilance & Recall records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.2s · Explored CAPA records & 14 regulatory clauses

P1 · Verified Agent Output· 24-Hour Event Triage & Locked Statutory Reporting Clock

Trigger real-time countdown timers and escalation alerts the moment a potentially reportable event is logged. CAPA workflow with bi-directional linkage

Open in CAPA

Global Investigation-to-MFDS CAPA Synchronization

Connect headquarters root-cause investigations and CAPA records directly to Korean follow-up and final vigilance filings.

Explore module

@Non-Conformance— Run "Global Investigation-to-MFDS CAPA Synchronization" across our Safety Vigilance & Recall records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.3s · Explored Non-Conformance records & 14 regulatory clauses

P1 · Verified Agent Output· Live Recall Lot Reconciliation & Customer Notice Tracker

Track hospital acknowledgment receipts, quarantined/returned unit counts, and destruction certificates with full audit trails. NC capture, classification, and disposition

Open in Non-Conformance

Service Specification

Service Scope & Final Deliverables

Scope

Continuous post-market safety monitoring, statutory reportability assessment, electronic submissions, and follow-up CAPA management under the Korean Medical Device Act.

  • Real-time adverse event and customer complaint intake across global and Korean channels
  • Legal assessment of MFDS reportability: 15-day expedited (death/serious injury) vs. 30-day standard
  • Drafting and electronic submission of statutory reports in Korean via the MFDS portal
  • Field Safety Corrective Action (FSCA) management and safety communication coordination
  • Annual vigilance summary reporting and integration into global quality management systems

Deliverables

Comprehensive, audit-ready adverse event logs and formal regulatory receipts from the Korean authority.

  • Live Korea Adverse Event Register with individual MFDS reportability evaluations
  • Official MFDS Electronic Submission Receipts (Initial, Follow-up, and Final Closure reports)
  • Field Safety Corrective Action (FSCA) coordination dossiers and communication logs
  • Quality system CAPA coordination memos and root cause investigation summaries
  • Annual MFDS Post-Market Vigilance Compliance Evaluation Report
Safety Vigilance & Recall — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Real-time adverse event and customer complaint intake across global and Korean channels
ScopeScope 2Legal assessment of MFDS reportability: 15-day expedited (death/serious injury) vs. 30-day standard
ScopeScope 3Drafting and electronic submission of statutory reports in Korean via the MFDS portal
ScopeScope 4Field Safety Corrective Action (FSCA) management and safety communication coordination
ScopeScope 5Annual vigilance summary reporting and integration into global quality management systems
WorkflowStage 1: Signal Intake & Complaint VerificationLog incoming complaints, adverse events, or global field safety signals into the Korea vigilance register.
WorkflowStage 2: Statutory Reportability DeterminationEvaluate event causality and severity against MFDS criteria to set the mandatory reporting window.
WorkflowStage 3: Expedited Electronic Submission to MFDSAuthor and submit initial statutory reports in Korean via the official MFDS portal before deadline expiry.
WorkflowStage 4: Root Cause Investigation & CAPA ClosureCollaborate with the manufacturing site on investigation findings, file follow-up reports, and close the incident.
DeliverablesDeliverable 1Live Korea Adverse Event Register with individual MFDS reportability evaluations
DeliverablesDeliverable 2Official MFDS Electronic Submission Receipts (Initial, Follow-up, and Final Closure reports)
DeliverablesDeliverable 3Field Safety Corrective Action (FSCA) coordination dossiers and communication logs
DeliverablesDeliverable 4Quality system CAPA coordination memos and root cause investigation summaries
DeliverablesDeliverable 5Annual MFDS Post-Market Vigilance Compliance Evaluation Report

Frequently Asked Questions

Yes. Foreign safety signals and overseas recalls concerning identical products must be reported to MFDS within statutory 15 or 30-day windows.

Upon receiving any deficiency notice from MFDS or a review body, our specialists dissect the reviewer’s statutory intent against historical clearance precedents. We separate items resolvable via technical justification from those requiring supplementary bench data, draft the complete formal response package, and manage reviewer alignment through final closure.

Yes. However, direct translation without regulatory reconciliation frequently triggers rejections due to standard edition mismatches or Korea National Deviations. We map your existing IECEE CB / ILAC test reports and global dossiers 1:1 against MFDS recognized standards to maximize evidence reuse and avoid redundant laboratory testing.

Our workflow is engineered to minimize engineering disruption. Once your team provides baseline source files (specifications, BOM, existing reports) during Stage 1 intake, Leanabl handles the heavy lifting: statutory mapping, Korean regulatory authoring, traceability matrix compilation, electronic portal filing, and agency correspondence. Your team only reviews and signs off at structured stage gates.

We immediately perform a regulatory change impact assessment to determine whether the modification requires a formal Technical File amendment, minor notification, or internal QMS documentation update. Because all deliverables are structured into modular digital assets, subsequent design iterations only require updating the affected sections rather than rebuilding the dossier from scratch.

Facing an Urgent Adverse Event or Field Safety Corrective Action?

Activate Leanabl’s vigilance taskforce immediately to meet statutory 7/15-day windows and protect your market authorization.

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