Korea · Cybersecurity & SBOM
Defensible Medical Device Cybersecurity Submission Packaging
Leveraging our proprietary MFDS review database to cut turnaround to 1/5 and systematically prevent recurring deficiency cycles, we prepare complete compliance packages for connected devices (Bluetooth, Wi-Fi, USB, Cloud): STRIDE threat modeling, machine-readable SBOMs (SPDX/CycloneDX), and post-market vulnerability response plans.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Submitted complete BLE threat models and standard SBOMs to secure first-round MFDS cybersecurity 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
Empirical SBOM Vulnerability (CVE/NVD) & STRIDE Threat Matrix Validation
100% Traceability Across SBOM Components, CVE Remediations & Security Tests
Engineered 4-Stage Workflow
A 4-Stage Pipeline from Threat Modeling to Submission-Ready Security Dossier
Locked System Architecture, DFD & Baseline SBOM
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 Post-Market SBOM Monitoring & Security Patch Governance
Live SBOM-to-Security-Risk Traceability
Connect software BOM components in PLM directly to security risk controls and verification evidence.
@Risk Management— Run "Live SBOM-to-Security-Risk Traceability" across our Cybersecurity & SBOM 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
Connect software BOM components in PLM directly to security risk controls and verification evidence. ISO 14971 risk register linked to design control
Automated Post-Market CVE Triage & Patch Change Control
Route newly disclosed vulnerabilities into structured impact assessments and regulatory change evaluations.
@Bill of Materials— Run "Automated Post-Market CVE Triage & Patch Change Control" across our Cybersecurity & SBOM 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 Bill of Materials records & 14 regulatory clauses
Keep MFDS security checklists, FDA TPLC plans, and customer MDS2 forms synchronized from a single source of truth. Multi-level BOM with revisions and comparison
Service Specification
Service Scope & Final Deliverables
Scope
We evaluate your security file the way a reviewer will, reporting exactly where documentation falls short of expectations.
- Threat model and security risk assessment documentation
- SBOM completeness, machine-readable formats, and transitive dependency coverage
- Security architecture, boundary definitions, and data-flow diagrams
- Vulnerability handling procedures and Coordinated Vulnerability Disclosure (CVD)
- Labeling instructions, patch controls, and post-market cybersecurity surveillance
Deliverables
Reviewer-ready audit findings accompanied by precise engineering remediation tasks.
- Clause-by-clause Cybersecurity Gap Matrix (findings, severity, regulation, owner)
- Regulatory Evidence Traceability Index
- SBOM Format Compliance & Known Vulnerability Assessment
- Remediation Sequencing Plan for Development & Regulatory Teams
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Threat model and security risk assessment documentation |
| Scope | Scope 2 | SBOM completeness, machine-readable formats, and transitive dependency coverage |
| Scope | Scope 3 | Security architecture, boundary definitions, and data-flow diagrams |
| Scope | Scope 4 | Vulnerability handling procedures and Coordinated Vulnerability Disclosure (CVD) |
| Scope | Scope 5 | Labeling instructions, patch controls, and post-market cybersecurity surveillance |
| Workflow | Stage 1: Documentation Intake & Completeness Check | Systematic ingestion of architecture diagrams, SBOM exports, risk files, and test records. |
| Workflow | Stage 2: Authority Guidance Cross-Mapping | Rigorous mapping against FDA §524B, EU MDCG 2019-16, and MFDS medical device cybersecurity guidelines. |
| Workflow | Stage 3: Threat Model & Component Deep-Dive | Detailed verification of threat vector coverage, known CVE mitigations, and crypto controls. |
| Workflow | Stage 4: Gap Matrix Delivery & Alignment Session | Delivery of prioritized findings and an executive walkthrough aligning software, regulatory, and quality leads. |
| Deliverables | Deliverable 1 | Clause-by-clause Cybersecurity Gap Matrix (findings, severity, regulation, owner) |
| Deliverables | Deliverable 2 | Regulatory Evidence Traceability Index |
| Deliverables | Deliverable 3 | SBOM Format Compliance & Known Vulnerability Assessment |
| Deliverables | Deliverable 4 | Remediation Sequencing Plan for Development & Regulatory Teams |
Frequently Asked Questions
Ready to Eliminate Cybersecurity Deficiency Risks for Your Connected Device?
Backed by our proprietary MFDS review database, we assemble defensible STRIDE threat models and standard SBOM packages in record time.