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SCOTTSDALE, AZ, UNITED STATES, November 15, 2024
Blue Goat Cyber, a leading provider of cybersecurity solutions for medical device manufacturers, is excited to announce the release of its latest white paper, “Cracking the Code: Insider Cybersecurity Insights for Medical Device Premarket Success.” This invaluable resource is now available for download on the Blue Goat Cyber website at www.bluegoatcyber.com.
Meeting the Growing Cybersecurity Challenge
As medical devices become increasingly interconnected, their vulnerability to cybersecurity threats grows exponentially. Research indicates that by 2025, approximately 70% of medical devices will be interconnected, creating a larger attack surface for malicious actors. This white paper offers timely, expert insights into the evolving regulatory landscape and provides actionable strategies for manufacturers to safeguard their devices.
Authored by Christian Espinosa, founder and CEO of Blue Goat Cyber, the white paper outlines critical components of effective cybersecurity strategies. Espinosa, a seasoned expert in the field, draws upon years of experience helping medical device manufacturers navigate complex FDA requirements to ensure their devices achieve market readiness.
Key Highlights of the White Paper
– Understanding FDA’s New Cybersecurity Requirements: With updates to the FDA’s guidelines in September 2023, manufacturers must now submit comprehensive threat models, Software Bill of Materials (SBOMs), and post-market monitoring plans. The white paper breaks down these requirements and provides tips for successful implementation.
– Secure Product Development Frameworks: Discover how early integration of cybersecurity into the design phase can save time and costs while enhancing patient safety.
– Top Five Reasons for FDA Submission Rejections: Insights into common pitfalls, such as inadequate threat modeling and risk assessments, help manufacturers avoid costly delays.
– Best Practices for Third-Party Penetration Testing: Understand the FDA’s preference for independent evaluations and learn how to select the right testing partner.
A Must-Read for Medical Device Manufacturers
This white paper is essential for regulatory affairs professionals, product developers, and cybersecurity teams. Whether you’re working on a 510(k) submission or post-market surveillance, the actionable insights provided will streamline your compliance efforts and enhance your device’s security posture.
“Cybersecurity is not just about regulatory compliance—it’s about ensuring patient safety and trust,” said Espinosa. “This white paper aims to empower manufacturers to meet stringent regulatory requirements while fostering innovation and safety in medical device development.”
Why Choose Blue Goat Cyber?
Blue Goat Cyber has a proven track record of assisting medical device manufacturers with cybersecurity compliance. It boasts a 100% success rate in helping clients achieve FDA clearance. With expertise in threat modeling, penetration testing, and regulatory support, Blue Goat Cyber stands at the forefront of medical device cybersecurity.
Availability and Access
The white paper, “Cracking the Code: Insider Cybersecurity Insights for Medical Device Premarket Success,” is now available for free download. Visit Blue Goat Cyber’s website to access this comprehensive guide and explore additional resources.
About Blue Goat Cyber
Blue Goat Cyber is a Service-Disabled Veteran-Owned Small Business dedicated to advancing cybersecurity in the medical device industry. Led by Christian Espinosa, the company specializes in providing robust, FDA-compliant solutions that integrate seamlessly into the product lifecycle, ensuring both regulatory approval and patient safety.
