From first design decision to post-market surveillance, MShield delivers purpose-built cybersecurity for medical device manufacturers navigating FDA and EU MDR compliance.
MShield addresses the specific threat surfaces and regulatory obligations of connected medical devices — from implantables to cloud-connected SaMD.
Cloud-connected SaMD faces the most complex regulatory landscape. MShield maps every software component to FDA and EU MDR cybersecurity requirements, automates SBOM generation, and maintains continuous compliance posture.
Implantable devices require the highest standard of security validation. MShield's risk-weighted scoring model applies ISO 14971 patient safety impact analysis to every vulnerability finding.
Internet of Medical Things (IoMT) devices introduce wireless attack surfaces across BLE, Wi-Fi, HL7, and DICOM protocols. MShield's threat taxonomy covers every communication layer.
Diagnostic systems handling patient data require both cybersecurity and data integrity compliance. MShield aligns security controls with FDA 21 CFR Part 11 electronic records requirements.
Security cannot be bolted on after development. MShield integrates directly into R&D workflows to surface threats at the architecture stage — before they become costly vulnerabilities.
Automated attack surface analysis mapped to your device's specific hardware, firmware, and communication protocols.
CycloneDX and SPDX-compliant Software Bill of Materials generated from your codebase and dependency tree.
Security architecture assessment against IEC 62443 security levels and FDA pre-submission expectations.
ISO 14971-aligned risk classification for every identified threat, weighted by patient safety impact.
Average residual risk score (0–100) across device submissions
No device should reach submission with unresolved vulnerabilities. MShield integrates into CI/CD pipelines to enforce security baselines at every build, automatically blocking non-compliant releases.
Cryptographic signing and integrity attestation for every build artifact, with tamper-evident audit logs.
Automated scanning integrated into GitHub, GitLab, Jenkins, and Azure DevOps — blocking builds that fail security thresholds.
Automated compliance matrix generation against FDA 510(k), De Novo, and EU MDR technical file requirements.
Structured documentation packages generated automatically, ready for regulatory submission without manual assembly.
Regulatory obligations do not end at market release. MShield provides continuous CVE monitoring, coordinated vulnerability disclosure management, and structured regulatory reporting for the full operational life of your device.
Continuous monitoring of deployed device components against the latest CVE feeds, filtered by device-specific relevance.
Structured CVD workflow aligned with FDA and EU MDR disclosure requirements, with stakeholder notification management.
Automated analysis of patch applicability, patient safety impact, and regulatory reporting obligations before deployment.
Structured reporting packages for FDA post-market cybersecurity obligations and EU MDR EUDAMED serious incident reporting.
SaMD faces the most demanding cybersecurity regulatory requirements. MShield's compliance engine is designed from the ground up for the SaMD lifecycle.
MShield maps obligations across all major regulatory frameworks
Request a live demonstration tailored to your device type and regulatory pathway. Our team will map MShield's capabilities to your specific compliance requirements.