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 5 of 30
https://www.youtube.com/embed/vRTOJaKxM7I In the rapidly evolving world of medical technology (MedTech), the ability to harness market intelligence and stay ahead of cybersecurity threats has become increasingly crucial for driving sustainable growth. As the industry continues to outpace regulatory
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Learn how ISO 13485, robust QMS, and strong cybersecurity help MedTech innovators avoid FDA rejections, navigate HIPAA vs FDA, and secure SAMD/SIMD devices.
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Learn how to organize FDA medical device cybersecurity requirements into 18 key deliverables, from threat modeling and SBOMs to testing and labeling.
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Learn the difference between SaMD and SiMD, why it matters for FDA strategy, and how to build secure-by-design medical devices across your product lifecycle.
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Written by Christian Espinosa Cybercriminals aren’t always who you expect. Most people believe hackers fit the mold from Hollywood movies. They’re either fringe radicals or nation-state actors. The reality is much more vanilla. Recently, two former cybersecurity firm employees were indicted and accu
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Two major medical device cybersecurity gaps - dispersed responsibility & missing asset inventories - fuel legacy and secondary-market risk. Learn how to close them.
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This episode of The Med Device Cyber Podcast unravels the often-misunderstood requirements for FDA cybersecurity premarket submissions. Hosts Christian Espinosa and Trevor Lynch demystify the 18 essential deliverables that map to the 13 sections of EAR 6.0, emphasizing that docum
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This episode of The Med Device Cyber Podcast features Kevin Saem from Zapirus, who discusses how market intelligence is revolutionizing the MedTech industry. Saem highlights the historical gap in regulatory and sales sophistication between MedTech and other life sciences, traditi
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This episode of The Med Device Cyber Podcast features Randy Horton of Orthogonal, a company specializing in software as a medical device (SaMD) development. The discussion emphasizes the critical need for integrating cybersecurity into the entire software development lifecycle - a
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This episode of The Med Device Cyber Podcast delves into the complex challenges of securing MedTech legacy devices, offering crucial insights for product security teams, regulatory leads, and engineers. The hosts discuss the FDA's evolving guidance on cybersecurity for devic
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Explore the FDA’s definition of a “medical cyber device” and learn how software, ports, and hidden connectivity can impact compliance and cybersecurity.
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Explore the FDA’s definition of a “medical cyber device” and learn how software, ports, and hidden connectivity can impact compliance and cybersecurity.
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