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Korea · Usability Engineering

Full-Scope Usability Engineering per IEC 62366 & MFDS Mandates

Powered by our proprietary MFDS review database that cuts turnaround times to 1/5 and systematically prevents recurring deficiency cycles, we deliver turnkey human factors execution from UI risk files to formative reviews and summative evaluations with Korean clinical users.

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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

Conducted ICU summative testing with 15 specialized nurses, securing full KGMP clearance.

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

Empirical Use-Error (uFMEA) Mapping & Summative Cohort Validation

100% Traceability Across Use Specs, uFMEA, UI Controls & Summative Tasks

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Use Specification to Complete UEF Delivery

Step 01 / 04Stage Gate & Output

Locked Use Specification, uFMEA & Critical Task List

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

Live uFMEA, UI Specification & Summative Traceability on Leanabl

Automated uFMEA-to-UI-to-Summative Traceability

Ensure every hazard-related use scenario maps directly to a UI design control and summative evaluation test case.

Explore module

@Risk Management— Run "Automated uFMEA-to-UI-to-Summative Traceability" across our Usability Engineering 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 Risk Management records & 14 regulatory clauses

P1 · Verified Agent Output· Locked Use Specification, uFMEA & Critical Task List

Ensure every hazard-related use scenario maps directly to a UI design control and summative evaluation test case. ISO 14971 risk register linked to design control

Open in Risk Management

Structured Use-Error, Close-Call & Root-Cause Logging

Capture summative test observations and subjective participant debriefs directly into ISO 14971 residual risk evaluations.

Explore module

@Requirements Management— Run "Structured Use-Error, Close-Call & Root-Cause Logging" across our Usability Engineering 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 Requirements Management records & 14 regulatory clauses

P1 · Verified Agent Output· UI Change Impact & Delta-Usability Assessment

Instantly trace how post-market GUI, alarm, or IFU updates affect critical tasks to justify targeted delta evaluations. Traceability from specification to verification

Open in Requirements Management

Service Specification

Service Scope & Final Deliverables

Scope

We mitigate use-related risks and build the defensible human factors evidence reviewers demand.

  • Intended use, user profile, use environment, and user interface specification
  • Use-related hazard identification and risk management integration (ISO 14971)
  • Identification and categorization of Critical Tasks tied to patient safety
  • Formative and summative usability evaluation protocol development
  • Complete Usability Engineering File (UEF) authoring for MFDS, FDA, and EU MDR

Deliverables

Reviewer-ready Human Factors dossiers satisfying FDA guidance, IEC 62366-1, and MFDS expectations.

  • Complete Usability Engineering File (UEF) conforming to IEC 62366-1
  • Use-Related Risk Analysis (URRA) Matrix
  • Critical Task Identification and User Interface Specification Document
  • Formative and Summative Human Factors Study Protocols & Final Reports
  • Executive Usability Summary for Pre-market Regulatory Filing
Usability Engineering — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Intended use, user profile, use environment, and user interface specification
ScopeScope 2Use-related hazard identification and risk management integration (ISO 14971)
ScopeScope 3Identification and categorization of Critical Tasks tied to patient safety
ScopeScope 4Formative and summative usability evaluation protocol development
ScopeScope 5Complete Usability Engineering File (UEF) authoring for MFDS, FDA, and EU MDR
WorkflowStage 1: Context of Use & User Profile ProfilingFormally define clinical environments, user characteristics, and interface touchpoints.
WorkflowStage 2: Use-Related Risk Analysis (URRA) & Critical TasksSystematically surface use errors and lock safety-critical tasks requiring validation.
WorkflowStage 3: Evaluation Protocol EngineeringDevelop rigorous formative and summative usability protocols with statistical sample justifications.
WorkflowStage 4: UEF Compilation & Regulatory Defense DebriefCompile complete Usability Engineering File with residual risk conclusions and executive briefing.
DeliverablesDeliverable 1Complete Usability Engineering File (UEF) conforming to IEC 62366-1
DeliverablesDeliverable 2Use-Related Risk Analysis (URRA) Matrix
DeliverablesDeliverable 3Critical Task Identification and User Interface Specification Document
DeliverablesDeliverable 4Formative and Summative Human Factors Study Protocols & Final Reports
DeliverablesDeliverable 5Executive Usability Summary for Pre-market Regulatory Filing

Frequently Asked Questions

Yes, if foreign reports comply with IEC 62366-1 and valid bridging arguments address Korean language UI and clinical practices.

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 Complete Your IEC 62366 Usability Engineering File?

Backed by our proprietary MFDS review database, we handle Korean clinician summative testing and KGMP audit defense end-to-end.

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