Every article in our archive tagged FDA.
Showing 12 of 52 articles tagged FDA · Page 2 of 5
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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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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Learn the difference between measures and metrics, FDA expectations, and how medical device makers use them to improve cybersecurity and protect patients.
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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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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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Proactive medical device cybersecurity drives faster FDA clearance, investor trust, and patient safety.
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Manufacturers in any industry often seek regulations as barriers or obstacles. They may add costs to production or layers of oversight. Those are usually not palatable to business, but in medical device cybersecurity, these rules are much more than red tape. The Food & Drug Administration (FDA) rece
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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 delves into the critical realm of postmarket surveillance for medical devices, addressing the ongoing need for security beyond pre-market approvals. Hosts Christian Espinosa and Trevor Slattery explore essential aspects of postmarket m
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This episode of The Med Device Cyber Podcast delves into the critical implications of Artificial Intelligence (AI) in medical devices, offering essential insights for product security teams, regulatory leads, and engineers. Christian Espinosa and Trevor Slattery explore the histo
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