Every article in our archive tagged Risk.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 7 of 19 articles tagged Risk · Page 2 of 2
Bluetooth in medical devices brings pairing, encryption, and spoofing risks. Learn BLE pairing modes, known attack classes, and what FDA guidance recommends that you test.
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How the WPA2 4-way handshake works, what KRACK broke, PSK vs 802.1X, and what medical device makers must document about Wi-Fi security for the FDA.
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VM escape lets attackers break out of a guest VM and compromise the hypervisor. Real-world examples, attack vectors, and mitigations for medical devices.
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Discover how to navigate the complexities of interoperable medical devices and effectively manage associated risks. Aligned with the FDA's Feb 3, 2026.
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Discover how medical devices are meticulously designed with patient safety as the top priority. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity.
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In this post, we unravel this complex issue of cyber threats in medical devices and discuss what manufacturers can do to make their devices more secure.
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The 50 most common cybersecurity issues in medical devices, why each matters for patient safety, and how penetration testing catches them pre-submission.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
