Medical Device Security
Comprehensive cybersecurity solutions for medical devices. From FDA pre-submission to post-market surveillance, we protect patient safety and data privacy.
End-to-End Security Coverage
Our comprehensive approach ensures your medical device meets the highest security standards.
FDA Pre-Submission Support
Expert guidance through the FDA cybersecurity pre-submission process, ensuring your device meets all regulatory requirements.
Risk Assessment
Comprehensive threat modeling and risk assessment following FDA guidance and IEC 62443 standards.
Penetration Testing
Thorough security testing of your medical device to identify vulnerabilities before they can be exploited.
Post-Market Surveillance
Ongoing monitoring and vulnerability management to maintain security throughout the device lifecycle.
Devices We Secure
We specialize in securing all types of connected medical devices.
Complete Security Services
Our medical device security services cover the entire product lifecycle, from design through post-market activities.
FDA Cybersecurity Guidance
We help manufacturers navigate FDA's cybersecurity guidance including:
- Pre-market Cybersecurity Submissions
- Post-market Management of Cybersecurity
- Cybersecurity in Medical Devices: Quality System Considerations
Ready to Secure Your Medical Device?
Schedule a consultation with our medical device security experts to discuss your needs.
Schedule Consultation