
QMSR is Here: From Checklist Compliance to Lifecycle Risk
Why February 2, 2026 was not just another regulatory date February 2, 2026 marked a watershed moment for the medical device industry. On that date,
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Why February 2, 2026 was not just another regulatory date February 2, 2026 marked a watershed moment for the medical device industry. On that date,

CVE-2025-36911, widely known as “WhisperPair,” recently exposed a critical class of vulnerabilities in Bluetooth audio accessories that rely on Google’s Fast Pair protocol. But here

The recent FDA Class I recall and safety alert involving Abiomed, Inc.’s Automated Impella Controller (AIC), due to cybersecurity vulnerabilities, is a powerful reminder that

The partnership will leverage EVSec platform with HARMAN’s Automotive Engineering Services capabilities to automate compliance and regulatory monitoring with US DoC 791D Rule Jerusalem, Israel,

The new capability is designed to give organizations the tools and automation they need to meet regulatory requirements quickly, confidently, and without slowing innovation Jerusalem,

What is an SBOM and why is it Important? A Software Bill of Materials (SBOM) is a foundational cybersecurity and compliance artifact that provides a

Why The New FDA Update Matters Right Now for MDMs The FDA’s Final Cybersecurity Guidance of June 2025 introduces significant new requirements under the FD&C

Introduction The EU’s Network and Information Systems Directive 2 (NIS2, Directive (EU) 2022/2555) came into effect in late 2024, establishing a new benchmark for cybersecurity

[Read the Chinese version of this announcement] Tel Aviv, Israel and Shanghai, China – July 30, 2025: C2A Security, the only context-driven product security orchestration
CRO
C2A Security
VP and GM, Medical Technology
C2A Security
Ken Zalevsky brings over 20 years of medical device cybersecurity experience to his role at C2A Security, where he serves as VP and GM, Medical Technology, following the acquisition of Vigilant Ops in October 2025. A former Bayer executive, Ken founded Vigilant Ops in 2019 after witnessing the consequences of inadequate technical preparation in the healthcare industry. He is an active contributor to CISA’s SBOM working groups and a frequent speaker on software supply chain security. Ken’s mission: transform SBOM from a compliance checkbox into operational intelligence that keeps patients safe while streamlining regulatory processes.