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 3 of 30
In this episode of The Med Device Cyber Podcast, hosts Christian and Trevor welcome Chris Danek, CEO of Bessel, to delve into the critical importance of early design decisions in shaping the success and cybersecurity of medical devices. The discussion emphasizes that robust cyber
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This episode of The Med Device Cyber Podcast features Brandon Ferdig, Senior Manager at Philips, who shares his unique journey from a 20-year Air Force career in IT and aviation to a leadership role in medical technology. Ferdig emphasizes the critical role of human factors and p
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This episode of The Med Device Cyber Podcast features Dr. Omar Ahmed, a professor of cardiac anesthesiology and critical care and co-founder of HIO, discussing the crucial role of integrating medical devices seamlessly into clinical workflows. Dr. Ahmed, a Key Opinion Leader (KOL
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This episode of The Med Device Cyber Podcast features Claudia from Polymos, a medical device marketing agency, discussing crucial strategies for effective medical device marketing. Key topics include precisely defining your target audience and crafting clear, concise messaging to
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In this episode of The Med Device Cyber Podcast, hosts Christian and Trevor welcome guest Steven Smith to delve into the critical intersection of quality assurance, regulatory affairs, and cybersecurity in medtech. Steven, with over two decades of experience in the MedTech space,
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The widespread, unauthorized use of AI diagnostic tools by medical professionals presents significant cybersecurity risks, as discussed in this episode of The Med Device Cyber Podcast. Despite regulatory frameworks such as IEC 62304 governing medical software development, nearly
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In episode 57 of The Med Device Cyber Podcast, hosts Christian and Trevor welcome Darcy Bachert, CEO of Prolucid, an ISO 13485-certified software development firm specializing in highly regulated industries like medical devices and nuclear. This episode pulls back the curtain on
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In this episode of The Med Device Cyber Podcast, Marc Zemel, co-founder and CEO of Rhae Medical, shares insights from his 15 years in MedTech, transitioning from a mechanical engineer at MIT to leading a medical device company. He discusses the evolution of medical technology, fr
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The Food and Drug Administration (FDA) has prioritized medical device cybersecurity in recent years. They issued updated guidance most recently on February 3, 2026. With cyberattacks increasing and products becoming more complex, they’re a target for hackers. The healthcare industry has long been
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The biggest MedTech startup mistake isn’t the tech. Learn why clarity, FDA planning, quality systems, and cybersecurity determine success.
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Postmarket medical device cybersecurity is a shared responsibility. See how manufacturers & healthcare organizations must collaborate to reduce operational risk.
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FDA’s QMSR is now in effect. See why connected MedTech teams must build cybersecurity into the QMS - risk management, V&V, suppliers, and postmarket.
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