Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 360 articles · Page 16 of 30
Updated April 17, 2025 ISO 13485, a globally recognized standard for quality management systems (QMS) in the medical device industry, is vital for ensuring medical devices' safety, effectiveness, and quality. It provides a framework for organizations designing, developing, producing, installing, and
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Updated October 26, 2024 The Federal Drug Administration (FDA) created medical device cybersecurity standards with its guidance most recently updated on February 3, 2026. The agency delivered explicit requirements and additional best practices within these new rules. One area of concentration was interoperability. So,
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Updated November 16, 2024 The latest FDA medical device cybersecurity update from the Food and Drug Administration (FDA) covers many security controls. Along with specific guidelines, the agency has also provided practical recommendations. This article will review the code, data, and execution integ
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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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CVD is mandated by Section 524B(b)(1) for FDA cyber device submissions. A practical guide to building a compliant CVD process for MedTech.
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The Federal Drug Administration (FDA) wants medical device manufacturers to follow its recommendations for security controls. This “advice” is part of the updated regulations for premarket submissions and postmarket monitoring. The document defines security control categories and how they can improv
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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. As part of the regulations for various regulatory bodies, it is crucial to have a clear and comprehensive test plan in place. This test plan covers many different aspects of what wil
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Updated October 26, 2024 Medical devices are often designed to connect to other devices and systems. This opens up extended functionality and the ability to rapidly move information and help patients in new ways. Unfortunately, this also expands a system's attack surface and often gives attackers th
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Discover the key differences between SPDF and TPLC in medical device cybersecurity.
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FDA 2025 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review delays.
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Learn how UEFI Secure Boot protects medical device systems from bootkits and tampering, plus key management, updates, pitfalls, and testing tips.
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Learn how MQTT technology can enhance cybersecurity for medical devices, ensuring the safety and privacy of patient data.
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