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Korea · AI/SaMD Authorization

End-to-End AI SaMD Approval & Innovative Device Fast-Tracking

Leveraging our proprietary MFDS review database to compress timelines to 1/5 and systematically prevent recurring deficiency cycles, we deliver turnkey regulatory authorization integrating IEC 62304 V&V dossiers, multi-center clinical performance reports (AUC, sensitivity, specificity), and SBOM security files.

Inquire About SaMD Approval

Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

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

Secured Innovative Device status and achieved full Class II NIDS certification in 45 days.

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

MFDS AI/SaMD Review Checklist, Clinical Dataset & PCCP Validation DB

100% Alignment with MFDS AI/SaMD Software V&V, Clinical Performance & PCCP Criteria

Engineered 4-Stage Workflow

4-Stage Authorization Pipeline from Dataset/Architecture Audit to MFDS Approval

Step 01 / 04Stage Gate & Output

AI Model Architecture, Training/Test Dataset & IEC 62304 Class Locked

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

Continuous AI Release Governance: SRS, SBOM & PCCP Change Control Automation

Automated Traceability: SRS ↔ Architecture (SDS) ↔ V&V & Anomaly Logs

Maintains live bi-directional links between software requirements, test execution logs, and unresolved anomaly justifications.

Explore module

@Requirements Management— Run "Automated Traceability: SRS ↔ Architecture (SDS) ↔ V&V & Anomaly Logs" across our AI/SaMD Authorization 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 Requirements Management records & 14 regulatory clauses

P1 · Verified Agent Output· AI Model Architecture, Training/Test Dataset & IEC 62304 Class Locked

Maintains live bi-directional links between software requirements, test execution logs, and unresolved anomaly justifications. Traceability from specification to verification

Open in Requirements Management

AI Model Retraining & PCCP Boundary Verification Log

Verifies whether algorithm weight updates remain within MFDS-approved PCCP performance envelopes or require formal amendment.

Explore module

@Risk Management— Run "AI Model Retraining & PCCP Boundary Verification Log" across our AI/SaMD Authorization 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 Risk Management records & 14 regulatory clauses

P1 · Verified Agent Output· Cloud & ML Pipeline SBOM / CVE Synchronization

Keeps Python/container dependencies, SBOMs, and MFDS cybersecurity checklists synchronized across every software build. ISO 14971 risk register linked to design control

Open in Risk Management

Service Specification

Service Scope & Final Deliverables

Scope

Directly author SDP, SRS, architecture designs, and traceability matrices mapped to code commits.

  • Software Files — Complete IEC 62304 lifecycle documentation set
  • Performance Validation — Independent dataset benchmark and demographic control files
  • Cybersecurity — Full cybersecurity packaging per MFDS Digital Health & Advanced Device Divisions rules

Deliverables

Complete SaMD & AI medical device technical documentation, PCCP, and cybersecurity deliverables under the Digital Medical Products Act.

  • Digital Medical Products Act classification justification and Korean SaMD Technical File
  • Algorithm architecture specification, training/validation dataset report, and clinical performance dossier
  • MFDS-compliant Predetermined Change Control Plan (PCCP) and model update validation protocol
  • Article 14 cybersecurity threat model, penetration test report, and machine-readable SBOM package
  • Official MFDS SaMD Premarket Approval / Certification license and deficiency defense log
AI/SaMD Authorization — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Software Files — Complete IEC 62304 lifecycle documentation set
ScopeScope 2Performance Validation — Independent dataset benchmark and demographic control files
ScopeScope 3Cybersecurity — Full cybersecurity packaging per MFDS Digital Health & Advanced Device Divisions rules
Workflow1. Lifecycle DocumentationDraft development files matching the IEC 62304 V-model.
Workflow2. Performance Validation DossierCompile clinical accuracy and dataset verification reports.
Workflow3. Cybersecurity PackagingGenerate SBOMs and complete threat modeling documentation.
Workflow4. MFDS AuthorizationDefend submissions before the Digital Bureau for final approval.
DeliverablesDeliverable 1Digital Medical Products Act classification justification and Korean SaMD Technical File
DeliverablesDeliverable 2Algorithm architecture specification, training/validation dataset report, and clinical performance dossier
DeliverablesDeliverable 3MFDS-compliant Predetermined Change Control Plan (PCCP) and model update validation protocol
DeliverablesDeliverable 4Article 14 cybersecurity threat model, penetration test report, and machine-readable SBOM package
DeliverablesDeliverable 5Official MFDS SaMD Premarket Approval / Certification license and deficiency defense log

Frequently Asked Questions

Yes. The Digital Medical Products Act institutionalized cloud-based SaMD approvals provided server security and SLA data are validated.

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.

Ready to Accelerate Your Digital Medical Device Approval in Korea?

Backed by our proprietary MFDS review database, our next-generation regulatory system cuts turnaround times to 1/5 and systematically prevents recurring deficiency cycles.

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