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 8 of 30
This episode of The Med Device Cyber Podcast features Monica Montañez of NAMSA, who provides crucial insights into the evolving landscape of medical device cybersecurity regulations, particularly following the September 2023 legislative changes. The discussion highlights the shif
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In this episode of The Med Device Cyber Podcast, the hosts delve into the intricacies of the four security architecture views mandated by the FDA for medical devices. They meticulously break down each view: the Global System View, Updatability and Patchability View, Multi-Patient
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This episode of The Med Device Cyber Podcast features Greg Garcia from the Health Sector Coordinating Council (HSCC), discussing the critical issue of shared responsibility in medical device cybersecurity. Garcia, with a background spanning the Department of Homeland Security and
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This episode of The Med Device Cyber Podcast delves into the critical concept of Total Product Lifecycle (TPLC) security, emphasizing its importance from concept to decommissioning for medical devices. Hosts Christian Espinosa and Trevor Lynch discuss how the Secure Product Devel
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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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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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This episode of The Med Device Cyber Podcast features Ash Garuli, principal and founder of Ingenious Solutions, discussing the critical intersection of cybersecurity and quality management in medical device development. Together with host Trevor Slatterie, Ash tackles common regu
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This episode of The Med Device Cyber Podcast delves into the critical but often misunderstood concept of cybersecurity labeling for medical devices. Hosts Christian Espinosa and Trevor Lynch clarify what labeling entails, addressing common misconceptions and outlining effective s
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In this episode of The Med Device Cyber Podcast, Mark Swanson and Steve Gumpertz from QRX Partners guide listeners through the complex world of medical device regulatory approval, emphasizing the critical role of robust quality systems and early expert engagement. They offer inva
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This episode of The Med Device Cyber Podcast delves into the critical aspects of post-market management and incident response for medical devices. Hosts Christian Espinoza and Trevor Slatterie dissect the process of addressing vulnerabilities once a device is in the field, moving
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This episode of The Med Device Cyber Podcast features Matt Lemay, CEO of Lemay.ai, discussing the critical intersection of AI in medical devices and regulatory compliance. The conversation delves into the challenges and opportunities for MedTech manufacturers in adopting AI, emph
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This episode of The Med Device Cyber Podcast delves into the critical role of software documentation for medical device manufacturers. Hosts discuss the imperative of comprehensive documentation to meet regulatory requirements, ensure product safety, and facilitate future mainten
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