Blue Goat Cyber specializes in medical device cybersecurity, offering tailored solutions for premarket and postmarket compliance, vulnerability mitigation, and patient safety.
Our founder, Christian Espinosa, named the company after his experiences as an avid mountain climber. Mountain goats represent resilience, focus, and determination—qualities that align with our mission to guide medical device manufacturers to secure and compliant solutions. "Blue" symbolizes trust, clarity, and limitless potential, reflecting our commitment to excellence and reliability.
We exclusively serve medical device manufacturers, including startups, mid-sized companies, and global leaders, ensuring compliance and security at every stage of the product lifecycle.
We stand by our work with a 100% success guarantee. If your device submission is delayed due to a cybersecurity deficiency, we will address and resolve the issue at no additional cost until your submission is approved. Our goal is to ensure your success and regulatory compliance without compromise.
Unlike general cybersecurity firms, we focus solely on medical devices. Our team’s deep understanding of FDA guidelines, AAMI TIR57, and global security standards ensures that we address the unique challenges of this industry.
We work with a wide range of devices, including IVD and diagnostic tools, wearable health devices, implantable devices, robotic surgical systems, SaMD, and legacy devices requiring updated cybersecurity measures.
We have a 100% success rate in helping manufacturers secure FDA approval, ensuring all cybersecurity requirements are met on the first attempt.
Our experts hold certifications such as CISSP, CSSLP, OSCP, CRTE, and CARTP, and have extensive experience in medical device cybersecurity, military cyber operations, and government red team testing.
Start by scheduling a free Discovery Session, where we’ll assess your cybersecurity needs and create a tailored strategy to secure your devices and ensure compliance.
Yes, every solution is customized to your device, its architecture, and your regulatory submission goals, ensuring a personalized and effective approach.
Our services are priced based on the complexity of your device and the scope of work required. We offer transparent, fixed-fee pricing with no surprises, ensuring you can budget confidently.
Timelines vary depending on the service, but most premarket projects, such as penetration testing and documentation support, are completed within 4–8 weeks.
We’ve partnered with leading manufacturers like Intuitive Surgical, bioMérieux, Nova Biomedical, Inogen, and Natera, as well as startups entering regulated markets for the first time.
Yes, in addition to FDA compliance, we help medical device manufacturers meet global regulatory standards, including:
Our team is experienced in navigating these and other international regulations, ensuring your devices meet the required cybersecurity standards for global markets.
Our team includes a core group of highly experienced cybersecurity professionals, each with specialized expertise in medical device security, regulatory compliance, and penetration testing. While we’re a focused team, we have the scalability to manage multiple devices or product lines simultaneously, ensuring every project receives the tailored attention it deserves.
We provide penetration testing, SBOM (Software Bill of Materials) management, threat tree development, SAST (Static Application Security Testing), secure design consulting, and FDA deficiency response.
Penetration testing identifies vulnerabilities in your device’s software, hardware, and networks, ensuring your device meets FDA cybersecurity requirements and is resilient to potential threats.
SBOM management ensures you track vulnerabilities in third-party and open-source software, aligning with FDA and AAMI TIR57 standards for supply chain security.
Threat model development maps out risks to your device, documents mitigation strategies, and ensures alignment with FDA cybersecurity expectations.
Static Application Security Testing (SAST) analyzes your device’s source code to identify vulnerabilities early in development, ensuring secure coding practices that prevent costly redesigns later.
Our secure design consulting integrates cybersecurity into your device development process from the start, reducing risks and aligning with FDA guidelines.
We deliver comprehensive, submission-ready reports, including test results, SBOMs, and threat tree documentation, ensuring your device meets FDA requirements.
We offer FDA deficiency response services that quickly address flagged cybersecurity issues, update documentation, and ensure your submission is resubmitted with confidence.
All our premarket services are designed to meet FDA cybersecurity requirements, ensuring your devices are compliant and ready for approval
We offer real-time threat monitoring, patch management, incident response, and legacy device security to keep your devices compliant and secure post-approval.
Cyber threats continue to evolve after FDA approval. Postmarket cybersecurity ensures ongoing compliance, protects patient safety, and safeguards your devices throughout their lifecycle.
Real-time threat monitoring continuously detects vulnerabilities and cyber threats, enabling immediate responses to prevent security incidents.
We assess vulnerabilities in older devices, implement tailored protections, and extend their lifecycle while ensuring compliance with FDA postmarket cybersecurity guidance.
We align all postmarket services with FDA guidance, AAMI TIR97, and global security standards, ensuring your devices meet ongoing safety and compliance requirements.
Yes, we align with international cybersecurity standards, including IEC 62304, ISO 14971, and EU MDR, ensuring compliance across multiple regions.
We’ve partnered with leading manufacturers, including Intuitive Surgical, bioMérieux, Nova Biomedical, Inogen, and Natera, as well as startups launching their first devices.
We provide end-to-end cybersecurity solutions, from premarket development to postmarket management, ensuring your devices remain secure, compliant, and trusted throughout their lifecycle.
Yes, we can manage multiple devices or product lines simultaneously. Our scalable approach ensures that each device receives tailored cybersecurity attention while streamlining workflows for manufacturers with larger portfolios.
We provide regular updates through check-ins, milestone reviews, and detailed reports. You’ll always have visibility into your project’s progress, timelines, and deliverables.
Our onboarding process begins with a free Discovery Session, where we assess your device’s needs and regulatory requirements. We then create a tailored plan, outline timelines, and assign a dedicated team to guide you through every step of the process.
We can start most projects within one to two weeks of the initial consultation, depending on the scope of work. For urgent needs, such as addressing FDA deficiencies, we can expedite timelines to prioritize your requirements.
