
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

And 2026 Will Be the Year Weak Programs Are Exposed 2025 did not bring a single defining cyber catastrophe. Instead, it delivered a steady accumulation

Product security teams are not struggling because they lack data. They are struggling because they have too much of it and too little context to

AI has become a lucrative and low-risk operational asset for cybercriminals. Research showed that artificial intelligence (AI) tools now power 80 percent of ransomware attacks,

In early December 2025, the IEC released an interpretation sheet to clarify important aspects of IEC 81001-5-1, the international standard for securing health software and

Catching Critical Vulnerabilities Before They Become Recalls The medical device industry has recently witnessed one of the most severe cybersecurity failures in its history. A

AI Red Teaming as a Blueprint for Proactive Product Security AI has significantly expanded red teaming capabilities, introducing new attack surfaces for models and the
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.