Two Key Device Security Documents Hospitals Need Now
When it comes to medical device security risk, hospitals are largely in the dark. By deploying medical devices without a […]
Benefits For Medical Device Manufacturers
Automated CBOM Generation, Collaboration, and Sharing
Automated Creation and Continuous Maintenance of CBOMs
Documentation for Regulatory Filings or to Include with Prospect Collateral
Controlled CBOM Distribution Through our Secure Platform
Improved Brand Image and Security Posture
BENEFITS FOR HEALTHCARE DELIVERY ORGANIZATIONS
Continuous Monitoring of Medical Device Software Components
Automated Consumption of CBOMs
Real-time Security Monitoring of Software Components
Awareness of Threats Across Deployed Devices
Improved Focus on Patient Safety
Ken Zalevsky, CEO at Vigilant Ops, has over seventeen years of experience in the medical device industry, most recently as Head of Medical Device CyberSecurity at Bayer.
Ken is an active participant and member of the software cybersecurity teams of several industry trade associations including MITA (Medical Imaging Technology Alliance) and AdvaMed (Advanced Medical Technology Association). Ken has been a featured speaker on medical device cybersecurity and related topics at various industry events including the Medical Device R&D Summit and the FDA Premarket Guidance Public Workshop. Ken has been the contributing author to multiple medical device cybersecurity whitepapers including CSP-1-2015 CyberSecurity in Medical Imaging and CSP 2-2018 Cyber Hygiene Best Practices and is also the author of Effective Strategies Must Protect Medical Devices, featured in DotMed Healthcare Business News.
Ken earned a certification in CyberSecurity Leadership from Carnegie Mellon University, an undergraduate degree in Applied Math from Carnegie Mellon University and a graduate degree in Business Management from Carnegie Mellon University. Ken also attended the Executive Education program at Harvard Business School.
FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk.
