01
Device-Specific Threat Taxonomy
A curated taxonomy of attack vectors specific to medical device hardware, firmware, communication protocols (HL7, DICOM, Bluetooth LE, Wi-Fi), and cloud-connected SaMD components.
HL7 / DICOMBLE / Wi-FiFirmwareSaMD
Platform Architecture
The MShieldPlatform
A proprietary data model built exclusively on medical device threat intelligence — not adapted from generic security frameworks. Every layer is designed for the regulated lifecycle.
Proprietary Data Model
Threat Intelligence Built for Medical Devices
Generic CVE feeds miss the attack surfaces that matter in medical devices. MShield's data model maps vulnerabilities to device-specific risk profiles, component hierarchies, and regulatory obligations.
02
Risk-Weighted Vulnerability Scoring
CVSS scores are insufficient for medical devices. MShield overlays patient safety impact, device criticality, and regulatory exposure to produce a risk score aligned with ISO 14971.
ISO 14971Patient SafetyCVSS+
03
Regulatory Obligation Mapping
Every finding is automatically mapped to the applicable regulatory control — FDA 21 CFR Part 11, EU MDR 2017/745, or IEC 62443 — so remediation is always compliance-aware.
FDA 21 CFREU MDRIEC 62443
04
Continuous Model Updates
The threat model is updated continuously from MShield's proprietary dataset, coordinated vulnerability disclosures (CVD), and regulatory guidance updates — not on a quarterly patch cycle.
CVD IntegrationReal-TimeRegulatory Feeds
Lifecycle Architecture
Security Integrated at Every Development Gate
MShield connects to your development pipeline at each phase gate, providing automated security validation before work advances.
R&D
Design & Development
Security requirements are defined at the architecture stage. MShield generates threat models, identifies attack surfaces, and produces SBOM artifacts aligned with FDA pre-submission expectations.
Phase Outputs
- Threat model report
- SBOM (CycloneDX / SPDX)
- Architecture risk assessment
- IEC 62443 gap analysis
Technical Architecture
Designed for Enterprise Integration
MShield integrates with existing development toolchains, quality management systems, and regulatory submission workflows — without replacing them.
Enterprise-grade infrastructure
01Integrations
Development Toolchain
- GitHub / GitLab / Bitbucket
- Jira / Azure DevOps
- Jenkins / GitHub Actions
- SonarQube / Veracode
02Platform Core
MShield Engine
- Proprietary threat intelligence model
- Risk scoring and prioritization
- Compliance automation engine
- Audit trail and evidence management
03Outputs
Regulatory & QMS Outputs
- FDA submission packages
- EU MDR technical file artifacts
- QMS integration (Greenlight Guru, Veeva)
- SBOM registries and export
Regulatory Frameworks
Three Frameworks. One Platform.
FDA 21 CFR Part 11 & Cybersecurity Guidance
MShield aligns with FDA's 2023 Cybersecurity in Medical Devices guidance, covering pre-market submission requirements, SBOM mandates, and post-market monitoring obligations.
- Pre-market cybersecurity documentation
- SBOM generation and maintenance
- Coordinated vulnerability disclosure policy
- Post-market monitoring and patching
EU MDR 2017/745 — Annex I & Annex II
Full alignment with EU MDR cybersecurity requirements under Annex I (General Safety and Performance Requirements) and Annex II (Technical Documentation).
- GSPR cybersecurity requirements (Annex I)
- Technical documentation (Annex II)
- Post-market surveillance system
- Serious incident reporting (EUDAMED)
IEC 62443 — Industrial Cybersecurity
Security level assessment and zone/conduit modeling for connected medical devices, aligned with IEC 62443-3-3 system security requirements.
- Security level (SL) assessment
- Zone and conduit modeling
- Foundational requirements (FR) mapping
- Security management system (CSMS)
See the Platform in Action
Request a live demonstration and see how MShield's proprietary data model maps to your device's specific threat surface and regulatory requirements.