Vigilant Ops, Inc.

Thank you DomainTools for featuring Ken Zalevsky on Breaking Badness Cyber Podcast! ??

Discover the critical role of Software Bill of Materials (SBOMs) in safeguarding healthcare systems in our exclusive interview with Joseph Silvia, CEO at Medware Cyber and Ken Zalevsky, CEO at Vigilant Ops. In this discussion, they dive into: ??Why SBOMs are essential for securing healthcare systems. ??How current SBOMs may miss critical vulnerabilities and the risks that arise. ??What medical device manufacturers need to know to protect their products—and patients. Watch the full interview and explore how we’re addressing these challenges: https://hubs.la/Q02ZHql30 #SBOM #Healthcare #MedTech #Cybersecurity #MedicalDevices

November 2024 Issue – Cyber Defense Magazine “The Critical Role of SBOMs In Defending MedTech from Software Supply Chain Threats” by Ken Zalevsky #cybersecurity #SBOM https://lnkd.in/e6ZszyD9

As cyberattacks increasingly exploit hidden vulnerabilities in software supply chains, organizations must prioritize transparency and security. Our latest blog post explores why SBOMs (Software Bill of Materials) are essential for tackling supply chain threats, meeting regulatory demands, and improving operational efficiency. From FDA mandates in #healthcare to global initiatives like the EU Cyber Resilience Act, SBOMs are more than a compliance tool—they’re a necessity for staying ahead. ?? Read the full article to learn how #SBOMs can safeguard your software: https://hubs.la/Q02Zxyts0

Just 1 week until Health-ISAC's 2024 Fall Americas Summit in Phoenix, AZ! ?? Visit Vigilant Ops at booth #30 to explore how our SBOM management platform streamlines visibility, #compliance, and cost efficiency for healthcare cybersecurity. ?? Dec 2–6, 2024 ?? Schedule time with us: https://hubs.la/Q02ZknJl0 #SBOM #HealthISAC #HISAC #medicaldevice #healthcare #cybersecurity #healthtech Alicia Bond Ken Zalevsky

From the Q&A of our webinar: How to Avoid Pitfalls When Planning an FDA Submission Q: How does sharing this information with the FDA work in the context of PCCP and AI-ML enabled devices? A: When it comes to sharing information on predetermined change-control plans (PCCP) for AI/ML solutions, it's crucial to adhere to the current draft guidance provided by the FDA. While this is still a draft and subject to change, aligning with it now sets a strong foundation for future compliance. For finalized guidance, the FDA’s software guidance, particularly section VI.B (page 13, last bullet point), should be your primary reference. Staying ahead of these evolving requirements is key to ensuring a smooth submission process. Interested in learning more or have another question for our team of experts? Let us know! [email protected]

“The Critical Role of SBOMs (Software Bill of Materials) In Defending Medtech From Software Supply Chain Threats,” article by Ken Zalevsky was featured in the Cyber Defense Magazine for their November 2024 issue. Learn more: https://hubs.la/Q02YYPhj0

From the Q&A of our webinar: How to Avoid Pitfalls When Planning an FDA Submission Q: How can we address the cybersecurity challenges posed by legacy devices, and what are the most effective strategies for remediating them to ensure compliance? A: Managing legacy devices that cannot be updated or changed is a challenging situation, often stemming from gaps in the initial development process. The most effective approach is to bring the device up to date with the latest operating systems and software. This proactive strategy is typically more straightforward than justifying to the FDA why updates can't be made, as valid reasons for non-compliance are rare. Create and maintain a Software Bill of Materials (SBOM) for legacy devices. Even if the device itself cannot be modified, an SBOM can help identify and track potential vulnerabilities, allowing for targeted mitigation efforts or planning for future device replacement. Interested in learning more or have another question for our team of experts? Let us know! [email protected] #Cybersecurity #SBOM #LegacyDevices #Compliance #FDA #MedTech

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Don't miss the November issue of Cyber Defense Magazine! Ken Zalevsky, CEO of Vigilant Ops, authors "The Critical Role of SBOMs in Defending MedTech from Software Supply Chain Threats" on page 48. ?? Read here: https://hubs.la/Q02XHnv40 #SBOM #MedTech #SoftwareSupplyChain #Cybersecurity #CyberDefense