Medical Device Security

Exploitation of a connected medical device can directly impact patient health. Securing devices is no longer optional—it’s a regulatory, ethical, and operational imperative. Hospitals, healthcare providers, and insurers demand assurance that connected devices can operate safely within clinical environments and hospital networks.

At RedBlue Cyber, we provide end-to-end cybersecurity solutions for medical device manufacturers, healthcare technology developers, and digital health innovators. Our mission is to help you design, build, and maintain medical devices that are secure, compliant, and resilient in the face of evolving threats.

Whether you're developing implantable devices, wearables, hospital-connected systems, or Software as a Medical Device (SaMD), we help you meet the rigorous security demands of today’s regulatory and threat landscape.

We deliver a structured, risk-based security program that aligns product cybersecurity with the expectations of the FDA, EU MDR, ISO 14971, IEC 62443, ISO 81001-5, and other international standards.

Outcomes We Deliver

  • STRIDE and LINDDUN threat models

  • Security architecture analysis (device, mobile, cloud)

  • Attack surface identification and mitigation

  • Risk scoring integrated with ISO 14971 hazard analysis

  • SBOM (Software Bill of Materials) generation and Supply-chain security guidance

  • Pre-market submission packages: Risk Management Plans, Threat Models, and Security Use Cases

  • Support for FDA Cybersecurity Guidance (2023) and Health Canada requirements

  • Alignment with ISO 80001 for post-market security

  • Post-Market Security & Incident Readiness including Coordinated Vulnerability Disclosure (CVD) program

Service Pricing

Get a free quote for service hourly rate, weekly rate, one-time assessment, or monthly retainer. We have generous discounts and bonus for new clients, bulk service, referrals, pilot projects, multi-month retainer, non-profit organizations, bundled packages and many more. Find your suitable Discounts HERE and let us know in your free quote.