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Risk· Sep 29, 2025

Mastering Cybersecurity in MedTech: The Key to Accelerating Innovation and Ensuring Patient Safety

Learn how MedTech innovators can turn cybersecurity into a competitive advantage. Avoid FDA delays, build trust, and accelerate time-to-market.

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Risk· Jul 13, 2025

PATCH Act Only Applies to New Medical Devices, Leaves Legacy Systems a Risk

With the Food and Drug Administration’s (FDA’s) 2023 requirements for medical device cybersecurity and the PATCH Act, regulators focused on reducing risk. However, the Patch Act only applies to new medical devices manufactured after March 2023. As a result, legacy systems have few checks around vuln

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Risk· Jul 13, 2025

Ventilator Recalled for Cybersecurity Risk: Was a Lack of Secure by Design the Cause?

A recent cybersecurity risk recall of a ventilator serves as a real-life demonstration of the security risks that persist. The Food & Drug Administration (FDA) characterized this as a Class 1 recall. This designation means the issues could threaten patient safety. The manufacturer pulled the device

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Risk· Nov 17, 2024

Medical Device Safety vs Security Risks

Explore the critical distinctions between safety and security risks in medical devices.

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Risk· Oct 24, 2024

Medical Device Cybersecurity Risk Profiles

Learn about the potential cybersecurity risks associated with medical devices in this comprehensive article.

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Risk· Apr 7, 2024

A Guide to FMEA for Medical Devices: Including Cybersecurity Failure Modes

Learn FMEA for medical devices with practical examples - including cybersecurity failure modes - so QA/RA and engineering teams can prioritize risk and actions.

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Risk· Mar 31, 2024

Medical Device Hazard Analysis and Critcal Control Points

Learn why medical device hazard analysis and critical control points are crucial for ensuring the safety and effectiveness of medical devices.

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Risk· Mar 24, 2024

Signed vs. Unsigned Integers in Medical Device Software: Security & Safety Implications

Explore the crucial disparities between unsigned and signed integers in this comprehensive article.

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Risk· Feb 28, 2024

Bluetooth in Medical Devices: Understanding the Risks and Protecting Patient Safety

Discover the fascinating world of Bluetooth technology with this comprehensive guide to the different types of Bluetooth.

#Risk#Networking

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Risk· Feb 25, 2024

Where Did 2600 Come From? What It Teaches About Medical Device Cyber Risk

The origin of “2600” has a modern lesson: how to rank medical device cyber risk, prioritize fixes, and document decisions for regulated products.

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Risk· Feb 22, 2024

WPA2 4-Way Handshake Vulnerabilities: What Medical Device Teams Need to Know About Wi-Fi Risk

Understand WPA2’s 4-way handshake, real risks like KRACK and weak passphrases, and practical mitigations for connected medical device Wi-Fi ecosystems.

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Risk· Feb 15, 2024

VM Escape in Medical Device Cybersecurity: Risk and Mitigations

VM escape breaks VM isolation to reach the host or hypervisor. Learn MedTech scenarios, controls, and evidence for FDA-aligned security.

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