THE LSI SUMMIT IS 4 DAYS AWAY! The LSI Summit is a game-changer for the MedTech industry, bringing together pioneers, investors, and experts to shape the future of healthcare technology. Public Relations Manager Nicole Amelio, M.A., sat down with Blue Goat Cyber CEO Christian Espinosa, to discuss: ?? The impact of the LSI Summit on the MedTech community ?? The critical role of cybersecurity in safeguarding medical devices ?? How Blue Goat Cyber is helping companies navigate compliance & security ?? The Road Trip to California! As the medical device landscape advances, so do the risks. At Blue Goat Cyber, we are committed to ensuring patient safety and regulatory compliance through cutting-edge cybersecurity solutions. ?? Watch the full discussion now: https://lnkd.in/gkedUXep ?? Learn more about the LSI Summit here: https://lnkd.in/gxxpcpK5 Join us as we continue to drive cybersecurity excellence in MedTech! #BlueGoatCyber #LSISummit #MedTech #Cybersecurity #MedicalDeviceSecurity
Blue Goat Cyber
专业服务
Scottsdale，Arizona 3,057 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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Want investors to say YES? Avoid this dealbreaker. According to a recent Husch—Blackwell article, raising capital in highly regulated industries like medical devices, biotech, and digital health presents unique challenges. Regulatory ambiguity is a dealbreaker—investors want clarity on whether a company is pursuing a 510(k), De Novo, PMA, or Breakthrough Device Designation for medical devices or an IND/NDA/BLA pathway for pharmaceuticals. Uncertainty in regulatory strategy raises risk and can stall funding. Companies that proactively engage with the FDA—through pre-submission meetings, securing a Breakthrough Designation, or obtaining investigational exemptions—demonstrate credibility and reduce investor concerns. ?? Read more here: https://lnkd.in/gJ_cskfP Need assistance with FDA compliance? Reach out here - we can guide you. www.bluegoatcyber.com #Investing #MedTech #Biotech #RegulatoryStrategy #Startups #RaisingCapital #Compliance #Entrepreneurship
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?? Mark your calendars – Blue Goat Cyber Webinar #5 is coming on March 26th! ?? Struggling with FDA cybersecurity compliance for medical devices? Now’s your chance to get expert guidance—LIVE! Failing to meet the latest FDA cybersecurity guidelines can lead to: ? Submission delays & rejections ? Costly remediation efforts ? Increased regulatory scrutiny Don’t wait until it’s too late! Join Christian Espinosa (CEO) and Trevor Slattery (CTO) of Blue Goat Cyber for Webinar #5 on March 26, where they’ll break down what you need to know and answer your questions LIVE! ?? What You’ll Learn: ?? The latest FDA cybersecurity requirements explained ?? Best practices for risk management (ISO 14971 & AAMI TIR57) ?? How to ensure secure software development & SBOM compliance ?? LIVE Q&A – Ask Christian & Trevor your questions in real-time! ?? March 26th– Save the Date! ?? Register now: ?? https://lnkd.in/gEtH8qcD or go to: https://lnkd.in/g6SJiWTs #MedTech #MedicalDeviceSecurity #Cybersecurity #FDACompliance #RiskManagement #BlueGoatCyber #LiveQandA #Webinar5 #MarkYourCalendars
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Hacking Wheelchairs?! 60mph? Cybersecurity Risks! Explore the cybersecurity risks of Class 2 devices, focusing on wheelchair vulnerabilities. Learn about potential hacks, speed modifications, and safety concerns. Discover how firmware manipulation can compromise wheelchair functionality and user safety. This video is a must-watch for wheelchair users and cybersecurity enthusiasts! #WheelchairCybersecurity #Class2Devices #IoTsecurity #MedicalDeviceSecurity #AccessibleTech #CyberRisks #FirmwareSecurity #TechSafety #DisabilityTech #DataPrivacy
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YOU SPENT YEARS ON YOUR INNOVATION. IS YOUR MEDICAL DEVICE SUBMISSION AT RISK? The FDA is reinforcing the importance of reliable testing data in medical device approvals. With an increase in concerns over third-party testing data integrity, the FDA has encountered challenges in assessing safety, effectiveness, and regulatory compliance—which can lead to delays, additional review steps, or even approval setbacks. For manufacturers and sponsors, ensuring accurate, high-quality data is key to a smoother approval process and faster patient access to life-changing medical technologies. By working with trusted testing partners and maintaining strong quality controls, companies can help avoid unnecessary obstacles and support innovation in healthcare. Stay ahead of the curve and learn more about the FDA’s latest guidance: https://lnkd.in/g36xknrF Reach out to our team today. We're here to help. www.bluegoatcyber.com #MedicalDevices #FDA #RegulatoryCompliance #DataIntegrity #MedicalDeviceTesting #PatientSafety
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Join Blue Goat Cyber for a valuable event on Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals on March 26. Mark your calendars to gain crucial insights.
Did you know that failing to meet the latest FDA cybersecurity guidelines can lead to: - Submission delays and rejections - Costly remediation efforts - Increased regulatory scrutiny Join this live webinar to: - Break down the FDA’s latest cybersecurity requirements - Master risk management best practices (ISO 14971 & AAMI TIR57) - Ensure secure software development and SBOM compliance - Get expert answers in a live Q&A with Christian Espinosa and Trevor Slattery Who Should Attend?: - Regulatory and Quality Professionals - Medical Device Manufacturers - Software and Product Managers - Cybersecurity and Compliance Teams Join Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, as they teach you how to stay ahead of evolving FDA requirements in medical device cybersecurity. Register now!https://lnkd.in/g6SJiWTs
Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals
www.dhirubhai.net
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Did you know that failing to meet the latest FDA cybersecurity guidelines can lead to: - Submission delays and rejections - Costly remediation efforts - Increased regulatory scrutiny Join this live webinar to: - Break down the FDA’s latest cybersecurity requirements - Master risk management best practices (ISO 14971 & AAMI TIR57) - Ensure secure software development and SBOM compliance - Get expert answers in a live Q&A with Christian Espinosa and Trevor Slattery Who Should Attend?: - Regulatory and Quality Professionals - Medical Device Manufacturers - Software and Product Managers - Cybersecurity and Compliance Teams Join Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, as they teach you how to stay ahead of evolving FDA requirements in medical device cybersecurity. Register now!https://lnkd.in/g6SJiWTs
Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals
www.dhirubhai.net
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Did you know that failing to meet the latest FDA cybersecurity guidelines can lead to: - Submission delays and rejections - Costly remediation efforts - Increased regulatory scrutiny Join this live webinar to: - Break down the FDA’s latest cybersecurity requirements - Master risk management best practices (ISO 14971 & AAMI TIR57) - Ensure secure software development and SBOM compliance - Get expert answers in a live Q&A with Christian Espinosa and Trevor Slattery Who Should Attend?: - Regulatory and Quality Professionals - Medical Device Manufacturers - Software and Product Managers - Cybersecurity and Compliance Teams Join Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, as they teach you how to stay ahead of evolving FDA requirements in medical device cybersecurity. Register now!https://lnkd.in/g6SJiWTs
Navigating FDA Cybersecurity Compliance: A Guide for RA/QA Professionals
www.dhirubhai.net
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FDA Regulations: Medical Device Safety Explore the impact of regulations on medical device testing and security. We discuss how new FDA guidelines influence device testing and the positive effects of regulations on enhancing device safety in the medical market. Discover our insights into navigating the regulatory landscape. #MedicalDevices #FDARegulations #DeviceTesting #MedicalDeviceSecurity #RegulatoryLandscape #Healthcare #MedTech #MedicalTechnology #Regulations #HealthTech
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Blue Goat Cyber is Heading to LSI 2025 – March 17-21 in Dana Point, CA! Next week, our team will be at the LSI USA Summit, engaging in discussions on medical device cybersecurity and connecting with industry leaders. Our Public Relations Manager, Nicole Amelio-Casper, sat down with CEO Christian Espinosa, VP of Med Tech Solutions Rick Turner, and VP of Strategic Partnerships Melissa Espinosa to discuss our excitement for the LSI USA Summit! Here’s where you can find us at LSI: ?? Christian’s workshop, "The Silent Killer" – A discussion on overlooked cybersecurity risks in MedTech on March 19th. ?? Melissa at Table #3 – Stop by, say hello, and pick up some Blue Goat Cyber swag! ?? Rick joining Christian’s workshop – Sharing his insights on securing medical devices. We’re looking forward to meaningful conversations, new connections, and important discussions about cybersecurity in healthcare. ?? Watch the conversation: https://lnkd.in/gSgGGuuY #BlueGoatCyber #LSI2025 #MedTech #Cybersecurity #HealthcareSecurity #DanaPoint #MedicalDevices
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