FREE WEBINARWhat the FDA Really Cares About in Your Cybersecurity Package as a part of 510k Premarket notification.25 February 202510am PST / 1pm EST60 minsCybersecurity isn’t just a checkbox in your 510(k) submission—it’s a critical component of FDA approval. With increasing scrutiny on medical devices and their digital ecosystems, the FDA wants more than generic compliance language; they want proof that your product is secure, resilient, and safe for patients.Join Aerstone’s experts in this exclusive webinar to uncover what the FDA really looks for in your cybersecurity package. Learn how to meet regulatory expectations, avoid costly delays, and build trust with your stakeholders—all while staying ahead of evolving threats. Register Now What to expectNInsightful PresentationsLearn from Aerstone’s cybersecurity experts as they share practical strategies for addressing FDA cybersecurity expectations, including how to prepare a robust Software Bill of Materials (SBOM) to demonstrate transparency and manage third-party software risks effectively.NInteractive Q&A SessionBring your questions to our live Q&A session and get clear, expert answers about SBOM requirements, FDA priorities, and how to align your 510(k) submission with regulatory expectations.NValuable InsightsGain insider knowledge on crafting a compliant cybersecurity package, with actionable tips to streamline your regulatory pathway and ensure your medical device is secure, resilient, and patient-safe. Who is it for?Medical Device Innovators preparing for FDA 510(k) submissions.Regulatory and Quality Professionalsnavigating cybersecurity compliance.Product Managers responsible for cybersecurity and risk mitigation.Startups and SMEs in MedTechlooking to streamline their regulatory pathway.Reserve your seat for expert insights and actionable strategies to strengthen your submission. SAVE YOUR SPOTMeet the Host Frank Schugar, CISSPCEO of AerstoneWe are thrilled to introduce Frank Schugar, CISSP, military veteran, and CEO of Aerstone, as the host of this webinar. With over 25 years of invaluable experience in the cybersecurity field, Frank brings a wealth of knowledge and expertise to the table.Prior to his role as CEO of Aerstone, Frank served as a Division Manager at SAIC, where he led the Federal-Civil Information Security Financial Sector for seven years. During his tenure, he spearheaded numerous initiatives aimed at enhancing cybersecurity measures for government and private sector clients alike.Frank’s strategic vision is unmatched, thanks in part to his background as a former U.S. Army Intelligence Officer. His unique perspective and deep understanding of cybersecurity challenges enable him to provide invaluable guidance and leadership to both clients and the Aerstone team.Secure Your SpotDon’t Let Cybersecurity Hold You Back – Sign up for our webinar and fast-track your 510(k) submission success.FREE WEBINAR:What the FDA Really Cares About in Your Cybersecurity Package Tuesday, Feb 25th10 am PT / 1pm ET Register NowWon’t be able to make it? Sign up to receive the recording. About AerstoneAerstone is a service-disabled, veteran-owned small business and one of only five NSA-Certified Vulnerability Assessors globally. We have over 2 decades of experience in providing intelligence grade security for the government and commercial organizations. All of our experts are U.S. based, hold a government clearance, and are ready to get to work for your Medtech company.
