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 15 of 30
Discover the potential risks and vulnerabilities associated with M2M communication in medical devices, and the critical importance of cybersecurity in safeguarding patient safety and data privacy.
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Discover the ins and outs of the IVD Regulation in medical device cybersecurity in this insightful article.
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Discover everything you need to know about FDA deficiency letters for medical devices in this comprehensive article.
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Discover the crucial intersection between medical device cybersecurity and ISO 9001 in this insightful article.
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Discover how implementing a Secure Software Development Life Cycle (SSDLC) can significantly bolster cybersecurity measures for medical devices.
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Updated November 16, 2024 Maintaining compliance with regulatory requirements is crucial in the rapidly evolving medical device manufacturing field. The Corrective and Preventive Action (CAPA) process is a cornerstone among these requirements. CAPA is a systematic approach to identifying, addressing
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Updated October 26, 2024 The development, manufacturing, and management of medical devices require strict regulatory adherence to ensure these products' safety, effectiveness, and reliability. A key regulatory framework governing this process is 21 CFR Part 820, often called the Quality System Regul
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JavaScript RCE can compromise device backends, portals, and update services. Learn common causes and FDA-aligned controls to prevent it.
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Explore FDA’s Quality System Regulation (QSR) for medical device cybersecurity, including key guidelines, compliance strategies, and best practices for safety.
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Updated November 10, 2024 In the medical device industry, Good Manufacturing Practices (GMP) form the foundation for ensuring the safety, effectiveness, and quality of devices that enter the market. These practices are crucial for maintaining regulatory compliance and meeting the high standards expe
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Updated November 16, 2024 Medical devices are integral to healthcare, ranging from simple tools like bandages to complex machines like pacemakers. The U.S. Food and Drug Administration (FDA) classifies these devices into three categories based on their risk level and intended use. This classificatio
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Learn how IEC 62304 supports medical device cybersecurity - secure software lifecycle, risk controls, and FDA-ready evidence to speed submissions and reduce risk.
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