Software as a Medical Device

At RedBlue Cyber, we specialize in delivering security solutions for Software as a Medical Device (SaMD) that balance compliance, performance, and protection across the entire product lifecycle.

SaMD applications are often deployed across mobile, web, and cloud platforms. This complexity introduces cybersecurity risks that can impact patient safety, data integrity, and regulatory approval. A compromised SaMD can result in incorrect diagnostics, missed alerts, or loss of critical health data.

With our deep experience in product security engineering and medical regulatory compliance, we help SaMD developers meet the security demands of regulators like the FDA, EMA, and Health Canada, while also building resilient, secure-by-design applications that can scale with confidence. We don’t treat SaMD like just a software. We treat it like software that protects lives.

Security Service Delivery:

  • Threat Modeling & Risk Analysis:

    Use of STRIDE and LINDDUN methodologies to identify privacy and security threats across data flow diagrams, APIs, and cloud services.

    Use of DREAD, CVSS, and Brainstorming to score risks.

Secure SDLC:

  • Security-by-design guidance from architecture to deployment.

  • Integration of SAST, DAST, dependency scanning, and SBOM generation.

Premarket Security Documentation:

  • Cybersecurity documentation for FDA premarket submissions.

  • Cybersecurity Risk Management Plan and Risk Assessment aligned with FDA Cybersecurity Guidance.

  • SBOM in SPDX or CycloneDX format.

Cloud & API Security:

  • Secure cloud architecture reviews

  • API security design and reviews

Post-Market Cybersecurity:

  • Coordinated Vulnerability Disclosure (CVD) process setup

  • SaMD Incident response planning

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.