CyberMed.AI
CyberMed is dedicated to securing the future of healthcare by providing expert cybersecurity solutions tailored for medical devices. Their mission emphasizes patient safety, business protection, and regulatory compliance, especially in navigating FDA cybersecurity requirements. With a leadership team experienced in cybersecurity, software development, and regulatory affairs, CyberMed offers comprehensive services including cybersecurity consulting, FDA documentation, testing, and ongoing post-market cybersecurity management. They focus on building secure, compliant, and resilient medical devices through structured risk assessments, architecture design, and continuous security practices.
Industries
Nr. of Employees
small (1-50)
CyberMed.AI
2100 N Alafaya Trl, Ste 500, Orlando, FL 32826
Services
Technical advisory and program support to identify vulnerabilities, select controls, design secure architectures, integrate cybersecurity into design controls and QMS, and provide program governance guidance.
Produce the required cybersecurity and software artifacts for premarket submissions, including architecture views, threat model, risk assessment, SBOMs, test plans, security control documentation, management plans, and traceability matrices.
Independent execution of security testing across web, mobile, cloud, and embedded components, including fuzzing and static/dynamic analysis, with formal test reports and remediation guidance for engineering and regulatory use.
Fixed-duration sprint that delivers architecture documentation, threat modeling, SBOM analysis, prioritized testing (fuzz & pen testing), final cybersecurity reports, and a checklist mapping artifacts to submission locations.
Review software development documentation and design history files to identify gaps against regulatory and cybersecurity expectations, and provide a prioritized remediation plan and documentation templates.
Technical advisory and program support to identify vulnerabilities, select controls, design secure architectures, integrate cybersecurity into design controls and QMS, and provide program governance guidance.
Produce the required cybersecurity and software artifacts for premarket submissions, including architecture views, threat model, risk assessment, SBOMs, test plans, security control documentation, management plans, and traceability matrices.
Independent execution of security testing across web, mobile, cloud, and embedded components, including fuzzing and static/dynamic analysis, with formal test reports and remediation guidance for engineering and regulatory use.
Fixed-duration sprint that delivers architecture documentation, threat modeling, SBOM analysis, prioritized testing (fuzz & pen testing), final cybersecurity reports, and a checklist mapping artifacts to submission locations.
Review software development documentation and design history files to identify gaps against regulatory and cybersecurity expectations, and provide a prioritized remediation plan and documentation templates.
Expertise Areas
- Medical device cybersecurity program development
- FDA premarket cybersecurity submissions and eSTAR documentation
- Threat modeling and security architecture for regulated devices
- Security testing: penetration testing, fuzzing, SAST/DAST, and software composition analysis
Key Technologies
- Penetration testing (black/white/grey-box)
- Fuzz testing
- Threat modeling (STRIDE, attack trees)
- Data Flow Diagrams (DFDs)
News & Updates
The FDA released an updated cybersecurity guidance document, providing clarification and emphasizing the importance of cybersecurity in medical device regulation.
CyberMed highlights how their services can help medical device companies avoid delays caused by cybersecurity deficiencies during FDA submission.
CyberMed offers a 30-day program to deliver FDA-ready cybersecurity documentation and testing, helping companies secure FDA clearance efficiently.
An overview of the FDA's recent updates to cybersecurity guidance, including new sections, scope clarifications, and industry standards.
The FDA released an updated cybersecurity guidance document, providing clarification and emphasizing the importance of cybersecurity in medical device regulation.
CyberMed highlights how their services can help medical device companies avoid delays caused by cybersecurity deficiencies during FDA submission.
CyberMed offers a 30-day program to deliver FDA-ready cybersecurity documentation and testing, helping companies secure FDA clearance efficiently.
An overview of the FDA's recent updates to cybersecurity guidance, including new sections, scope clarifications, and industry standards.