Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 292 articles · Page 15 of 25
How javaScript RCE Attacks target medical devices, real-world examples, and the controls FDA expects manufacturers to implement in 2026.
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Explore FDA's Quality System Regulation (QSR) for medical device cybersecurity: key guidelines, compliance strategies, and best practices for MedTech.
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GMP Cybersecurity Compliance for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
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How IEC 62304 supports medical device cybersecurity: secure software lifecycle, risk controls, and FDA-ready evidence to speed premarket submissions.
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How ISO 13485 quality management underpins medical device cybersecurity, and what FDA reviewers expect to see linked to your QMS in a 524B submission.
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FDA medical device cybersecurity standards and interoperability considerations: what the Feb 2026 guidance requires for connected device submissions.
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Ensure medical device security with robust code, data, and execution integrity controls. Learn how FDA guidance shapes premarket cybersecurity for devices.
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NFC and BLE risks in medical devices: real attack patterns, hype vs reality, and practical design and postmarket controls for proximity interfaces.
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FDA Authentication & Authorization Controls for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
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Identifying a scope for the penetration test of a medical device is a vital stage of the test plan development phase. Aligned with the FDA's Feb 3, 2026.
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Updated October 26, 2024 Medical devices are often designed to connect to other devices and systems. Aligned with the FDA's Feb 3, 2026 premarket.
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SPDF vs TPLC in medical device cybersecurity: how the Secure Product Development Framework maps to Total Product Life Cycle expectations from the FDA.
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