Primer· Nov 17, 2024
Securely Updating Medical Devices
Discover essential best practices and strategies for ensuring secure updates in medical devices.
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Primer articles.
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Showing 12 of 127 articles tagged Primer · Page 3 of 11
Primer· Nov 16, 2024
Embedded Cybersecurity Challenges in Medical Devices
The embedded-systems cybersecurity challenges that derail FDA premarket submissions - from constrained crypto to firmware update integrity - and how to evidence them under §524B and the SPDF.
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Primer· Nov 16, 2024
Cybersecurity Practices for Protecting Medical Devices: Manufacturer’s Checklist
Updated November 17, 2024 Medical devices have ushered in a new age of healthcare driven by innovation and technology. These additions to the ecosystem of care offer benefits for providers and their patients. However, manufacturers must adapt to regulatory requirements with cybersecurity practices f
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Primer· Nov 10, 2024
Telemedicine Cybersecurity Risks for Connected Medical Devices
Remote care expands the attack surface of connected medical devices. Key telemedicine cybersecurity risks and FDA-aligned mitigations for MedTech.
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Primer· Nov 10, 2024
IVD Medical Device Cybersecurity Concerns
Explore the critical intersection of in vitro diagnostics (IVD) and cybersecurity in this insightful article.
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Primer· Nov 2, 2024
MedTech Augmented Reality Cybersecurity
Explore the critical cybersecurity risks associated with augmented reality (AR) medical devices.
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Primer· Nov 2, 2024
QNX Vulnerabilities in Medical Devices: Risks & Mitigations
QNX runs in infusion pumps, imaging consoles, and surgical robots. A MedTech-focused look at QNX vulnerabilities and FDA-aligned mitigation strategies.
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Primer· Nov 2, 2024
Dissecting the Therac-25 Incident
Explore the harrowing tale of the Therac-25 incident, a pivotal case study in medical device failures.
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Primer· Oct 27, 2024
What Is a Radiology Information System?
RIS meaning explained: what RIS software does, how RIS integrates with PACS/EHR using HL7 and DICOM, and key cybersecurity controls to reduce risk.
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Primer· Oct 27, 2024
IATF 16949 and MedTech Cybersecurity
Explore the intersection of IATF 16949 standards and medical device cybersecurity, uncovering how automotive quality management principles can enhance the safety and security of medical technologies in an increasingly connected world..
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Primer· Oct 27, 2024
Laboratory Information Systems (LIS): MedTech Cybersecurity Guide
LIS platforms exchange PHI with diagnostic devices. What MedTech manufacturers need to know about LIS security and FDA interoperability expectations.
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Primer· Oct 23, 2024
XXE Attacks Explained: Risks and Fixes for MedTech Software
Learn what an XXE attack is, how it impacts MedTech software, and the practical parser, testing, and lifecycle controls that prevent it.
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