Blue Goat Cyber provides tailored premarket cybersecurity services for medical device manufacturers, including penetration testing, threat modeling, SAST, secure product design consulting, and SBOM management. Aligned with FDA guidance and industry standards, our solutions ensure compliance, mitigate vulnerabilities, and streamline your path to regulatory approval.
Medical Device Cybersecurity Services
Our flagship services include medical device cybersecurity for FDA premarket submissions, penetration testing, and postmarket management.
Cybersecurity Risks Are Evolving—Is Your MedTech Innovation Ready?
Cyberattacks are growing in frequency and sophistication, and for medical device manufacturers, the stakes couldn’t be higher. The question is no longer if your device will face a cyber event—it’s when. Are your devices secure enough to meet regulatory standards, protect patient safety, and maintain trust post-launch?
Threats are persistent and evolving, targeting vulnerabilities at every stage of your device’s lifecycle. Whether you’re preparing for FDA premarket approval or managing cybersecurity postmarket, one-size-fits-all solutions simply don’t work.
At Blue Goat Cyber, we offer tailored solutions for both premarket and postmarket needs:
- Premarket Services: Penetration testing, threat modeling, and FDA-compliant documentation to ensure your device meets stringent cybersecurity requirements and secures regulatory approval.
- Postmarket Services: Real-time threat monitoring, patch management, and legacy device security to safeguard your devices long after they’re on the market.
Ready to secure your devices? Schedule a no-cost Discovery Session to learn how we can help you protect your innovations and the patients who rely on them.
With Blue Goat Cyber, you’ll gain the confidence to navigate cybersecurity challenges at every stage—keeping your devices safe, compliant, and trusted.
Blue Goat Cyber offers comprehensive postmarket cybersecurity solutions, including real-time threat monitoring, patch management, incident response, and legacy device security. Our tailored services ensure ongoing FDA compliance, protect patient safety, and keep your devices secure throughout their lifecycle.
