『Pure Global: US MedTech Cybersecurity's SBOM Reckoning』のカバーアート

Pure Global: US MedTech Cybersecurity's SBOM Reckoning

Pure Global: US MedTech Cybersecurity's SBOM Reckoning

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概要

 A recent cybersecurity breach at a major US hospital, targeting connected infusion pumps, has sent shockwaves through the MedTech industry. The incident, which triggered a joint alert from the FDA and CISA, highlights the critical vulnerabilities that exist even in trusted medical devices and the immense pressure now on manufacturers. This episode of MedTech Global Insights unpacks the event and explores the new reality of cybersecurity compliance. We discuss the stringent new requirements from the FDA, including the mandatory Software Bill of Materials (SBOM), and how they align with the EU's MDR, forcing a complete lifecycle approach to device security. Imagine this scenario. a successful scaleup company finds its flagship diagnostic device, installed in hundreds of clinics, is suddenly vulnerable. A flaw was discovered not in their code, but in an open-source library their developers used years ago. Now, they face a regulatory nightmare, with market access at risk because they cannot prove to regulators they have a process to manage third-party software risks effectively. 本期干货: - Why is the latest US hospital breach a critical wake-up call for all IVD and MedTech firms globally? - What does the FDA's mandatory Software Bill of Materials (SBOM) *really* mean for your development team? - How do the EU MDR and FDA's cybersecurity guidances overlap, and where are the critical differences? - What are the most overlooked vulnerabilities hiding in legacy medical devices? - Is your post-market surveillance plan truly prepared for a zero-day exploit in third-party code? - How can you turn the burden of cybersecurity compliance into a competitive advantage and a mark of quality? - What crucial questions should you be asking your software suppliers and internal teams right now? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database.
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