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Korea · STED Gap Analysis

Pre-Submission STED Technical Dossier Gap Analysis

Audit FDA 510(k) and CE MDR files against MFDS submission mandates to isolate testing, raw material, and V&V gaps before filing.

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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

Identified missing coating composition data; fortified raw material dossier to achieve first-round MFDS approval.

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

Quantitative Auditing Against Historical Deficiency Databases

1:1 Cross-Check Against MFDS Reviewer Checklists & Standards

Engineered 4-Stage Workflow

A 4-Stage Pipeline from Dossier Intake to Remediation Plan

Step 01 / 04Stage Gate & Output

Locked Dossier Inventory & Baseline Freeze

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 Dossier Traceability & Remediation Tracking

Automated Claim-to-Evidence Cross-Linking

Maintain live links between technical file claims, ISO 14971 risk controls, and verification reports.

Explore module

@Document Control— Run "Automated Claim-to-Evidence Cross-Linking" across our STED Gap Analysis 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 Document Control records & 14 regulatory clauses

P1 · Verified Agent Output· Locked Dossier Inventory & Baseline Freeze

Maintain live links between technical file claims, ISO 14971 risk controls, and verification reports. Full document lifecycle with version control

Open in Document Control

Structured Gap Remediation Workflows

Assign each identified gap to R&D or RA owners with clear closure criteria and automated status tracking.

Explore module

@Risk Management— Run "Structured Gap Remediation Workflows" across our STED Gap Analysis 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· Global-to-Local Dossier Version Control

Keep master global technical files and localized MFDS STED packages synchronized with full audit trails. ISO 14971 risk register linked to design control

Open in Risk Management

Service Specification

Service Scope & Final Deliverables

Scope

We evaluate dossier completeness and scientific evidence against current regulatory expectations (MFDS, FDA, CE MDR).

  • Technical documentation (STED) completeness and structural adherence
  • General Safety and Performance Requirements (GSPR / Essential Principles) alignment
  • Preclinical safety, EMC, biocompatibility, and bench test report currency and scope
  • Software lifecycle (IEC 62304), cybersecurity, and usability engineering file audit
  • Clinical Evaluation Report (CER) and clinical equivalence rationale validation

Deliverables

Clear, reviewer-ready findings and an actionable remediation roadmap to preempt official deficiency letters.

  • Clause-by-clause Technical File / STED Gap Matrix
  • Test Report Currency & Supplemental Testing Assessment
  • GSPR / Essential Principles Compliance Gap Report
  • Clinical Evidence & CER Adequacy Evaluation
  • Prioritized Remediation Roadmap & Submission Timeline
STED Gap Analysis — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Technical documentation (STED) completeness and structural adherence
ScopeScope 2General Safety and Performance Requirements (GSPR / Essential Principles) alignment
ScopeScope 3Preclinical safety, EMC, biocompatibility, and bench test report currency and scope
ScopeScope 4Software lifecycle (IEC 62304), cybersecurity, and usability engineering file audit
ScopeScope 5Clinical Evaluation Report (CER) and clinical equivalence rationale validation
WorkflowStage 1: Dossier Intake & Baseline AuditSystematic receipt of existing technical documentation, test reports, risk management files, and change records.
WorkflowStage 2: Clause-by-Clause Gap MappingRigorous cross-checking against applicable MFDS notices, FDA guidance documents, and EU MDR regulations.
WorkflowStage 3: Testing & Clinical Evidence VerificationIn-depth assessment of laboratory accreditation, testing standard versions, and clinical data sufficiency.
WorkflowStage 4: Remediation Plan & Executive BriefingDelivery of prioritized deficiency matrix, remediation solutions, timelines, and strategic risk debrief.
DeliverablesDeliverable 1Clause-by-clause Technical File / STED Gap Matrix
DeliverablesDeliverable 2Test Report Currency & Supplemental Testing Assessment
DeliverablesDeliverable 3GSPR / Essential Principles Compliance Gap Report
DeliverablesDeliverable 4Clinical Evidence & CER Adequacy Evaluation
DeliverablesDeliverable 5Prioritized Remediation Roadmap & Submission Timeline

Frequently Asked Questions

No. While CE STED is a solid foundation, MFDS imposes strict unique mandates on raw material specs, test lab accreditations, and labeling, typically requiring 30–40% gap remediation.

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 Korean Regulatory Pathway?

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

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