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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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In this episode of The Med Device Cyber Podcast, hosts Trevor Slatterie and Christian Espinosa, joined by special guest William Jin, delve into the often-overlooked cybersecurity challenges that lead to medical device recalls and hinder market expansion. William Jin, with over 30
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This episode of The Med Device Cyber Podcast features Omar Khateeb, host of The State of MedTech podcast. Khateeb discusses the current landscape of the MedTech industry, highlighting a shift from a period of consolidation with a few large strategics to the emergence of "min
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This episode of The Med Device Cyber Podcast untangles the complexities of Software Composition Analysis (SCA) for MedTech teams. Hosts Trevor Slattery and Christian Espinosa demystify SCA, differentiating it from related concepts like SBOMs (Software Bill of Materials) and SOUP
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This episode of The Med Device Cyber Podcast delves into the critical and increasingly urgent issue of medical device cyber failures, exploring instances where vulnerabilities have led to direct patient harm, including fatalities. Hosts Trevor Slatterie and Christian Espinosa dis
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In this rapid-fire episode of The Med Device Cyber Podcast, Trevor Slattery provides expert answers to critical questions in medical device cybersecurity, offering invaluable insights for product security teams, regulatory leads, and engineers. The discussion covers essential sta
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This episode of The Med Device Cyber Podcast delves into the critical distinctions between black, gray, and white box penetration testing, specifically within the medical device cybersecurity landscape. Hosts discuss the varying levels of information provided to testers in each a
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In this episode of The Med Device Cyber Podcast, host Christian Torres and Trevor sat down with Jim Goodmiller from Bio Bridges to discuss the critical intersection of cybersecurity with regulatory and quality success in the medical device industry. Jim Goodmiller, with a unique
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This episode of The Med Device Cyber Podcast places Christian in the hot seat, addressing critical questions frequently posed by MedTech innovators. The discussion kicks off by demystifying ISO 13485, explaining its role in establishing robust quality management systems essential
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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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