5 Cybersecurity Myths That Put Your Medical Device Clearance at Risk скачать в хорошем качестве

5 Cybersecurity Myths That Put Your Medical Device Clearance at Risk

Cybersecurity misconceptions are quietly derailing medical device clearance. Teams assume “we’re not really a cyber device,” “this is just about data,” or “our developers already handle security”—and then get blindsided by FDA questions, global regulator feedback, or investor concerns late in the process. In this practical, no-fluff webinar, Christian Espinosa (Founder & CEO) and Trevor Slattery (CTO) of Blue Goat Cyber break down the five most common medical device cybersecurity myths they see across startups and scaling manufacturers—and show what FDA and global regulators actually expect instead. You’ll learn how to connect cybersecurity to patient safety and clinical risk, align with modern expectations for a Secure Product Development Framework (SPDF), and avoid the usual pitfalls: missing SBOMs, weak traceability, and “one-and-done” cyber studies that don’t hold up under review. Christian and Trevor will also share 2025 startup findings from recent device engagements—recurring cyber gaps that slow or complicate 510(k)s, De Novos, PMAs, and international submissions—so you can fix them before they threaten clearance or market access. In this webinar, you’ll learn: Myth #1 – “Cybersecurity is about the data.” Why regulators increasingly frame cybersecurity as patient safety and clinical risk, not just data confidentiality or HIPAA—and how to reflect that in your risk management story. Myth #2 – “My device isn’t a cyber device.” How FDA Section 524B and global expectations treat most software-enabled or connected products as cyber devices, even if they’re “mostly offline,” and what that means for your threat modeling and documentation. Myth #3 – “Cybersecurity is a one-time study.” Why regulators expect lifecycle cybersecurity—integrated into design, verification, release, and postmarket—not a single pen test or “cyber report” stapled on at the end. Myth #4 – “Our developers understand cybersecurity.” Where even strong engineering teams typically fall short of regulator-ready, secure development practices, and how to provide them with clear, practical guardrails instead of vague “do security” mandates. Myth #5 – “Cybersecurity is cybersecurity.” How medical device cybersecurity differs from traditional IT security—especially around safety, usability, and clinical workflows—and what that means for your testing, evidence, and messaging. Common Startup Gaps – 2025 Findings Christian and Trevor will also highlight the patterns they’re seeing again and again in 2025: Missing or incomplete SBOMs Weak linkage between vulnerabilities and patient harm Poor traceability from risks → controls → tests Cyber “owned” by IT instead of Quality / RA Thin postmarket cybersecurity and vulnerability processes …plus practical steps to close these gaps before reviewers, customers, or investors call them out. Who should attend: MedTech founders, CEOs, and CTOs Regulatory affairs and quality leaders (RA/QA) R&D and engineering teams building software-enabled or connected devices Anyone responsible for getting a medical device cleared and kept secure in the U.S., Europe, or APAC If you want your next device to be cyber-ready and clearance-ready, this session will show you what to stop assuming—and what to start doing—right now.