Security PostureAssessment Review
Upload your existing security assessment and receive a structured gap analysis against IEC 62443, NIST SP 800-30, and FDA cybersecurity guidance — with a prioritized remediation roadmap.
What We Assess Against
IEC 62443
Industrial automation and control system security standards applied to medical device contexts.
NIST SP 800-30
Risk assessment guide for information systems, adapted for connected medical device threat environments.
FDA 2023 Guidance
Current FDA cybersecurity guidance for premarket submissions and post-market management.
ISO 14971
Medical device risk management standard, with cybersecurity risk integration per latest amendments.
What You Receive
Gap Analysis Report
Structured findings mapped to each framework control, with severity ratings and evidence citations.
Remediation Roadmap
Prioritized action plan with effort estimates, ownership recommendations, and timeline guidance.
Submission Readiness Score
Quantified readiness rating for FDA premarket submission based on current security posture.
Executive Summary
One-page summary suitable for board, QA, and regulatory affairs stakeholders.
Submit Your Assessment for Review
Upload your existing security posture assessment, penetration test report, or threat model. Accepted formats: PDF, DOCX, XLSX. Up to 10 files, 20 MB total. All files handled under strict confidentiality.
Need a Full Security Assessment?
MShield can conduct end-to-end security testing for your device — from threat modeling through penetration testing.