Navigating FDA Cybersecurity Requirements Just Got Easier
We specialize in helping medical device manufacturers secure FDA 510(k) and PMA submissions with guaranteed results, ensuring compliance and protecting patients.
FDA Cybersecurity Guidance Is Complex. We Make It Simple.
The FDA’s updated cybersecurity guidance has introduced stricter requirements for medical devices, leaving many manufacturers overwhelmed. Whether you’re preparing your first submission or addressing deficiencies in a resubmission, navigating these requirements can be time-consuming, stressful, and costly if not done right.
The stakes are high:
- Delayed approvals can cost millions.
- Cyber vulnerabilities can threaten patient safety and your reputation.
At Blue Goat Cyber, we specialize in solving these challenges. With over a decade of experience and a 100% success rate in FDA cybersecurity submissions, we ensure your devices meet the highest standards of security and compliance.
Ready to simplify your FDA submission? Schedule your free Discovery Session today.
Introducing the FDA Compliance Package: A Complete Cybersecurity Solution
Our FDA Compliance Package is specifically tailored to address every aspect of the FDA’s cybersecurity requirements. It’s designed to save you time, reduce stress, and ensure your devices meet regulatory standards.
What’s Included:
- Comprehensive Documentation: Fully customized cybersecurity documentation aligned with FDA guidelines.
- Rigorous Testing and Analysis: Penetration testing, SAST, SBOM, and vulnerability analysis to identify and mitigate risks.
- Regulatory Expertise: Full alignment with FDA guidance, eSTAR, and global standards like EU MDR/IVDR.
Additional Benefits:
- Unlimited retests at no extra cost.
- Guaranteed FDA clearance or we resolve deficiencies for free.
Let us take the complexity out of FDA compliance. Contact us to get started.
Expertise You Can Trust
Specialized Focus
Over 10 years of experience exclusively in medical device cybersecurity.
Proven Results
Hundreds of successful FDA submissions, from diagnostic tools to robotic surgery systems.
Guaranteed FDA Clearance
If cybersecurity issues arise, we resolve them at no additional cost.
Lifecycle Support
We provide ongoing postmarket cybersecurity support, ensuring your devices remain secure after approval.
Personal Commitment
After a life-threatening health scare, our founder, Christian Espinosa, was inspired to make medical device security his mission.
Trusted by Leading Medical Device Manufacturers
We’ve helped manufacturers of all sizes—from startups to global leaders like Intuitive Surgical, Inogen, and Natera—secure FDA approvals with confidence. Here’s what one of our clients had to say:
“Blue Goat Cyber’s expertise ensured our FDA approval on the first try, saving us time and money.”
“They resolved our FDA deficiency issues quickly, getting us back on track without delays.”
“Their customized approach and deep understanding of medical device cybersecurity were unmatched.”
Join the hundreds of manufacturers we’ve helped achieve FDA success. Schedule your free Discovery Session today.
Your Path to FDA Compliance Starts Here
Let us handle the complexities of cybersecurity so you can focus on what matters most—patient care and innovation. Blue Goat Cyber’s FDA Compliance Package is your complete solution for navigating 510(k) and PMA cybersecurity requirements with confidence.
Get Started Today:
- Schedule a free Discovery Session.
- Receive tailored guidance for your device’s submission.
- Achieve FDA approval with guaranteed results.
