We Provide Full-Service medical Device Cybersecurity for Premarket Submissions & Postmarket Management

Call Us: (844) 939-GOAT (4628)

Tactical and Strategic Cybersecurity Services

Medical Device Cybersecurity Premarket Submission Services

We handle all the cybersecurity requirements for your medical device’s premarket submission, including thorough documentation, testing, and regulatory compliance.

Medical Device Cybersecurity Penetration Testing Services

We handle all third-party vulnerability assessments and penetration testing requirements for your medical device's FDA and EU MDR submissions, ensuring full compliance with both regulatory standards.

Medical Device Cybersecurity Postmarket Management Services

We specialize in delivering comprehensive postmarket cybersecurity support for medical device manufacturers, ensuring ongoing compliance with FDA and EU MDR requirements while maintaining device security and effectiveness throughout its lifecycle.

Full-Service and Full-Spectrum Cybersecurity Services to Secure Your Product and Business

At Blue Goat Cyber, we specialize in medical device cybersecurity, delivering tailored solutions to protect your devices, data, and patients from evolving cyber threats. Our expertise spans both premarket and postmarket phases, ensuring compliance with industry standards like FDA guidelines, IEC 62304, and ISO 14971 while minimizing cybersecurity risks.

Our medical device cybersecurity services include:

Pre-Market Cybersecurity Services

Threat modeling and risk assessments during design and development.
Verification and validation of cybersecurity measures to ensure compliance with regulatory requirements.
Comprehensive documentation support for FDA submissions and EU MDR/IVDR.

Post-Market Cybersecurity Support

Ongoing monitoring and threat detection to address emerging vulnerabilities.
Patch management and security updates to ensure continued device safety and performance.
Incident response planning and execution for cybersecurity events.

Penetration Testing

Identifying weaknesses in medical device software and network connections.
Proactively mitigating risks before they can be exploited.

We understand the high-stakes environment of the medical device industry, where safety, reliability, and compliance are critical. Our team specializes in navigating these complexities to deliver solutions that protect your devices and patients.

Ready to secure your medical devices?

Schedule a complimentary Discovery Session to learn how our tailored cybersecurity solutions can address your specific needs during both the pre-market and post-market phases.

Partner with Blue Goat Cyber—your trusted ally in securing the future of healthcare.

Years Experience

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Blue Goat Cyber's Purpose

To protect lives and advance healthcare by ensuring the security and trustworthiness of medical devices in an ever-evolving digital landscape.

Blue Goat Cyber's Vision

Securing life-saving medical devices with expert cybersecurity solutions that ensure compliance, enhance patient safety, and build trust.

Blue Goat Cyber's Mission

To safeguard medical innovations by delivering exceptional cybersecurity services, ensuring compliance, protecting patients, and empowering manufacturers to meet the highest standards of security and trust.

Blue Goat's Cybersecurity Beliefs

We believe in safeguarding patient safety and trust by protecting medical technologies from cyber threats

We believe in protecting private property

We believe everyone has the right to freely operate in cyberspace

We believe in using our skills to give back to our local and global community

We believe in developing and empowering people

What is it like to work with us?

We are a trusted partner with only one purpose – to help you succeed. We realize cybersecurity is probably not the main focus of your business and is often viewed as a “necessary evil.” We are not a “one-and-done” company. We value long-term relationships where we help you protect your data. We know if we add enough value for you, we will both succeed. Give us a chance.

What makes us unique?

Our people. Our employees are extremely certified in their respective areas of expertise, believe in our mission, and have many years of experience with government and commercial sectors. We are passionate about helping you secure your data.
Our Processes. We take security seriously and use a holistic approach. Many competitors begin by searching for vulnerabilities with a microscope. We start with the big picture.
Our services. We spend time writing our reports in a simple, easy-to-understand manner. We’re not impressed with competitors that generate thousand-page reports with lots of technical jargon that leaves you wondering, “What do I do with this”?

What do we value?

We value progress. We value relationships. We value attention to detail. We value aptitude. We value attitude. We value clear communications. We value a growth mindset. We value taking ownership. We value adaptability. We value stepping outside of comfort zones. We value thinking outside the box. We value creativity and innovation. We value persistence. We value wellness. We value learning. We value success. We value the journey.

Our purpose is simple – to secure your product and business from cybercriminals.

The number of cybersecurity incidents continues to climb. The variety of attacks continues to grow. It is no longer a question of if you will have a cyber event.

Testimonials

What they say about us.

We ensure you have a great experience with us.

Blue Goat Cyber was excellent. They helped my team understand our HIPAA cybersecurity posture and provided a clear and concise report with easy to follow recommendations. Highly recommend!

We needed our medical device assessed and penetration tested for our 510(k) FDA submission. BGC was fast and efficient and helped us with our submission. We spoke with many other vendors before choosing them, and we're glad we did.

We're a startup and needed a web application penetration test. Blue Goat's testing team is outstanding. They know what they are doing. We're glad we found Blue Goat.