Meet CyberMed, Bold Type's dedicated medical device cybersecurity division.

CyberMed was founded by cybersecurity leaders who literally wrote the book on securing medical devices. We support your journey through FDA cybersecurity compliance, from architecture to testing to post-market risk management.

Schedule Cybersecurity Consult Visit CyberMed Website

Core Capabilities

Comprehensive cybersecurity services designed specifically for medical device manufacturers navigating FDA requirements.

Security Architecture & Threat Modeling

STRIDE threat modeling, secure architecture design, and risk assessment specifically tailored for medical device ecosystems and FDA requirements.

  • STRIDE methodology implementation
  • Medical device threat landscapes
  • Secure architecture blueprints
  • Risk assessment matrices
  • Mitigation strategy roadmaps

Full Cybersecurity Documentation for FDA

Complete cybersecurity documentation packages that FDA reviewers understand and approve, following the latest guidance and industry standards.

  • Cybersecurity Device Files (CDFs)
  • SBOM (Software Bill of Materials)
  • Risk management documentation
  • Security controls matrices
  • FDA submission support

Technical Testing Services

Comprehensive security testing including penetration testing, vulnerability assessments, and fuzzing specifically designed for medical device environments.

  • Penetration testing (pen testing)
  • Vulnerability scanning & assessment
  • Fuzz testing for robustness
  • Network security analysis
  • Code review & static analysis

Post-Market Monitoring Support

Ongoing cybersecurity monitoring, incident response planning, and vulnerability management to maintain FDA compliance throughout the product lifecycle.

  • Continuous vulnerability monitoring
  • Incident response planning
  • Security patch management
  • Threat intelligence integration
  • FDA reporting assistance

What Our Clients Say

Trusted by medical device companies worldwide for cybersecurity excellence.

"Our device was cleared before the FDA updated its cybersecurity guidance in 2023. When we submitted an application to expand our indications, FDA sent a host of cybersecurity questions. CyberMed quickly prepared the documentation we needed to support clearance. When it comes to medical device cybersecurity, these guys are legitimate experts."
Jim O'Connor
CFO, Axena Health
"The CyberMed team is sharp, knowledgeable, and great to work with. They quickly reviewed our documentation, performed a cybersecurity gap analysis, and created a clear plan to secure our system and meet FDA requirements. Their expertise and efficiency made a huge impact—I highly recommend them to any medical device company."
Pierre-Alexander Fournier
CEO, Hexoskin
"For sophisticated systems that include embedded software, mobile applications, and cloud, CyberMed's expertise in cybersecurity is truly unparalleled in the industry. They've been a trusted partner for years and I couldn't recommend them more highly. Take it from someone who's been in IT and security for more than three decades."
Mike Fong
CEO, Privoro
"As the founder and publisher of MedTech Leading Voice, I have my finger on the pulse of the medical devices industry. With FDA's recent focus on cybersecurity, any medical device company hoping to commercialize a product with software needs a security expert on their side. CyberMed is unsurpassed in the industry. Their team is next level."
Sean Smith
Founder, MedTech Leading Voices

Ready to secure your medical device?

Don't let cybersecurity gaps delay your FDA submission. Get expert guidance from the team that literally wrote the industry standards.

Schedule Cybersecurity Consult Visit CyberMed Website