Full LifecycleCybersecurity Coverage
MShield integrates into every phase of your device program — from first design input through post-market surveillance — so security is never a last-minute checkbox.
Security at Every Stage
Threat Modeling at Design Origin
Identify attack surfaces and security requirements before the first line of firmware is written. MShield's proprietary data model maps STRIDE threats to device architecture in real time.
- STRIDE threat modeling
- Security architecture review
- Risk register generation
- Design input traceability
Evidence-Driven Security Testing
Automated vulnerability scanning, penetration test orchestration, and SBOM generation aligned to FDA cybersecurity submission requirements.
- Automated SBOM generation
- CVE triage and scoring
- Penetration test coordination
- Verification protocol authoring
Submission-Ready Documentation
Generate complete cybersecurity documentation packages for 510(k), De Novo, and PMA submissions — pre-formatted to FDA guidance and EU MDR Annex I requirements.
- 510(k) cybersecurity section
- Cybersecurity management plan
- CBOM and SBOM artifacts
- EU MDR Annex I mapping
Continuous Surveillance & Response
Ongoing threat intelligence feeds, coordinated vulnerability disclosure workflows, and FSCA documentation support to keep your device compliant through its full market life.
- Real-time CVE monitoring
- FSCA documentation
- Coordinated disclosure workflows
- Annual security review reports
See the Full Pipeline in Action
Request a live walkthrough of how MShield maps to your device program.