FDA Risk Assessment: Objective Metrics & CVSS Learn how objective metrics significantly improve risk assessment. We explore exploitability, a key metric, and its application in scoring risk. Discover how the FDA utilizes objective metrics and how CVSS offers valuable exploitability metrics for security risk assessments. Improve your risk assessment methodology today! #RiskAssessment #Cybersecurity #FDA #ObjectiveMetrics #Exploitability #CVSS #SecurityRiskAssessment #Metrics #RiskManagement #InfoSec
Blue Goat Cyber
专业服务
Scottsdale，Arizona 3,105 位关注者
We provide turnkey medical device cybersecurity services for FDA premarket submissions and postmarket management.
关于我们
Full-Service Medical Device Cybersecurity for Premarket Submissions and Postmarket Management Medical device manufacturers face immense pressure to innovate while ensuring patient safety and meeting rigorous FDA cybersecurity requirements. The complexity of these challenges can be overwhelming, with the risk of vulnerabilities threatening not just compliance but patient lives. You want to create life-saving devices that patients and healthcare providers can trust. But navigating cybersecurity requirements, building robust threat models, and preparing FDA submissions can pull focus away from your core mission. It’s easy to feel stuck, wondering if your device is truly secure and compliant. At the heart of the issue is a need for clarity, confidence, and guidance through the cybersecurity landscape. That’s where Blue Goat Cyber comes in. We specialize in helping manufacturers create secure devices that meet FDA eSTAR guidelines while protecting patient safety. Our proven processes, fixed-fee pricing, and expert support ensure that your devices are secure and compliant without disrupting your innovation. When you partner with Blue Goat Cyber, the path becomes clear. By addressing cybersecurity early, managing risks effectively, and implementing robust security measures, you can move forward with confidence. Your devices will not only meet regulatory expectations but also demonstrate your commitment to patient safety. Imagine the peace of mind that comes with knowing your devices are secure, compliant, and ready to improve lives. With Blue Goat Cyber’s guidance, you can focus on advancing technology while leaving cybersecurity challenges behind. Your reputation as a trusted innovator grows, and your patients are safer because of it. The stakes are high, but the solution is within reach. You’re building the future of healthcare—Blue Goat Cyber ensures nothing holds you back.
- 网站
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https://bluegoatcyber.com
Blue Goat Cyber的外部链接
- 所属行业
- 专业服务
- 规模
- 11-50 人
- 总部
- Scottsdale，Arizona
- 类型
- 私人持股
- 创立
- 2022
- 领域
- cybersecurity、penetration testing、medical device cybersecurity、web application penetration testing、FDA Compliance、510(k) cybersecurity、FDA Cybersecurity 、FDA Premarket Cybersecurity和MedTech cybersecurity
地点
Blue Goat Cyber员工
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Nicole Amelio, M.A.
Award-Winning Documentarian
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Christian Espinosa
Founder & CEO | MedTech Cybersecurity Podcast Host | 24x Ironman | Blood Clot Survivor->Thriver | Veteran | 2x Best-Selling Author | Keynote Speaker…
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Danielle Bentley
Sales | Naturopathic Student | Self Development | Team Leader & Builder | Soma Veda Thai Massage | Truth Seeker |
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Myles Kellerman
Principal Consultant
动态
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Regulatory Affairs Firms: Are your clients ready for FDA cybersecurity compliance? With the FDA’s 2023 cybersecurity guidance, medical device submissions face tougher scrutiny than ever. Without the right cybersecurity documentation, even solid applications can hit roadblocks—delays, deficiencies, or outright rejections. That’s where Blue Goat Cyber steps in. We specialize in partnering with Regulatory Affairs firms to ensure your clients' submissions are cyber-ready and FDA-compliant from day one. ? Why partner with us? ? 100% FDA cybersecurity approval rate ? Fixed-fee pricing & unlimited retests ? Proven referral program with dedicated partner support ? Trusted by top MedTech companies and consultants Let’s collaborate so you can focus on what you do best—regulatory strategy—while we handle the cybersecurity complexities. ?? Book a partner discovery call now: www.bluegoatcyber.com #RegulatoryAffairs #MedicalDeviceCompliance #CybersecurityPartner #FDAApproval #RAConsultants
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Medical Device Safety & Security Risks Explained Join Trevor as he explores the crucial similarities and distinctions between safety and security risk management frameworks in medical devices. Learn how these processes overlap and ensure comprehensive patient safety and data security in this insightful online discussion. #MedicalDeviceSafety #RiskManagement #Cybersecurity #DataSecurity #PatientSafety #MedicalTechnology #TPLC #ISO14971 #TIR57 #RegulatoryCompliance
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BIG congratulations to Vitestro on the official launch of Aletta – their autonomous phlebotomy device that’s set to revolutionize blood collection! Named after Aletta Jacobs, the trailblazing Dutch physician and women’s rights activist, this innovative device marks a significant leap forward in healthcare automation. With cutting-edge robotics and AI, Aletta can autonomously draw blood, streamlining workflows, reducing the burden on clinical staff and enhancing the overall patient experience. Vitestro’s commitment to reimagining clinical diagnostics is incredibly inspiring. Aletta isn’t just a device—it’s a bold vision of the future where technology and patient care work together to improve access, precision, and efficiency in healthcare delivery. At Blue Goat Cyber, we love celebrating medtech breakthroughs that prioritize patient safety and innovation. This is a huge step for the industry, and we’re excited to watch Aletta impact labs and clinics across Europe and beyond. Read the full story: https://loom.ly/7GJDaM4 #MedTechInnovation #Vitestro #Aletta #HealthcareAutomation #PatientExperience #MedicalDeviceInnovation
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Cybersecurity: Functional vs. Non-Functional Requirements Explore the critical world of device security with our insightful discussion on authentication, functional vs. non-functional requirements, and the perception of cybersecurity. Learn how to strengthen your security measures and understand the importance of both functional and non-functional aspects. #Cybersecurity #DeviceSecurity #Authentication #Cybersecurity #DeviceSecurity #Authentication #FunctionalRequirements #NonFunctionalRequirements #SecurityRequirements #PasswordProtection #DataSecurity #InformationSecurity #Tech
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What happens when AI in medical devices is quietly compromised from the inside? That’s the unsettling reality of data poisoning—where bad actors inject malicious data into an AI’s training set, corrupting its ability to make accurate decisions. It’s like a slow poison, subtly altering outcomes that could impact patient safety. This isn’t just a tech issue—it’s a human one. In this Blue Goat Cyber blog (link below), we explain how data poisoning works, why it’s a growing threat in medical device AI, and, most importantly, how to defend against it. Let’s stay ahead of these evolving cybersecurity risks. Read the full article here: ?? https://lnkd.in/gwZ_yQb6 #Cybersecurity #MedicalDevice #AI #PatientSafety #BlueGoatCyber
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Medical Device Professionals – Are you prepared for the latest FDA cybersecurity requirements? Join Christian Espinosa (CEO) and Trevor Slattery (CTO) of Blue Goat Cyber for the next live webinar that breaks down what you need to know to avoid: ? Submission delays and rejections ? Costly remediation ? Increased regulatory scrutiny ? Learn how to navigate evolving FDA guidelines ? Master risk management (ISO 14971 & AAMI TIR57) ? Ensure secure software development + SBOM compliance ? Ask your questions LIVE with two leading experts ?? Who should attend? Regulatory & Quality pros | Med Device Manufacturers | Product Managers | Cybersecurity & Compliance Teams ?? Team Blue Goat Cyber is here to guide you—no matter your stage in your device development journey. Let’s get your device to the finish line—securely and compliantly. Did you miss the last Webinar? Check it out here: https://lnkd.in/gy_WhBnc. Here's a teaser. #BlueGoatCyber #MedicalDeviceCybersecurity #FDACompliance #MedTech
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The energy at LSI USA 2025 was something special. Our team at Blue Goat Cyber walked away not just inspired—but deeply moved by the shared commitment to innovation, safety, and purpose across the medtech community. From early-stage startups to seasoned leaders, every conversation echoed a collective drive to make healthcare better, smarter, and more secure. What stood out the most? The human side of this work. Behind every device is a person whose life could be changed—or even saved. That’s what grounds us in cybersecurity. It’s not about fear, it’s about protection, trust, and care. Thank you to everyone who came by our booth, asked thoughtful questions, and shared their stories. We’re grateful for the chance to learn from and with you. Let’s keep the momentum going. Follow us here to stay connected: ?? https://lnkd.in/gNGuNpnR #LSIUSA2025 #BlueGoatCyber #MedTechWithPurpose #CybersecurityMatters #PatientFirst #MedicalDeviceSecurity #TechForGood #GratefulConnections
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Med Device Cybersecurity: Do it EARLY & OFTEN! Tune in to the Med Device Cyber Podcast, where we discuss crucial pre-submission strategies for medical device cybersecurity. Learn how early planning and collaboration with experienced regulatory affairs professionals can streamline the FDA review process and prevent costly delays. #MedDeviceCybersecurity #Podcast #FDA #MedicalDevices #Cybersecurity #Regulations #RegulatoryAffairs #Submissions #TimeManagement #Efficiency
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We’re honored to highlight Melissa Espinosa, our VP of Strategic Partnerships at Blue Goat Cyber! Melissa’s journey is nothing short of inspiring—after years as a dedicated nurse, she transitioned into medical device cybersecurity, bringing a deep understanding of patient care and healthcare technology. Her unique perspective ensures that cybersecurity solutions prioritize both compliance and patient safety. At Blue Goat Cyber, Melissa is leading strategic initiatives to help medical device manufacturers navigate FDA cybersecurity requirements, strengthen industry partnerships, and enhance security in healthcare. We’re proud to have her on our team! Join us in celebrating Melissa’s incredible work. Thank you Melissa for your dedication at this week's LSI USA 2025 summit! ?????? #EmployeeSpotlight #Cybersecurity #MedicalDevices #FDACompliance #Healthcare #Leadership #BlueGoatCyber
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