Every article in our archive tagged Risk.
Showing 12 of 47 articles tagged Risk · Page 1 of 4
In this interview, Brent Lavin of Ironwood MedTech Partners, discusses de-risking product decisions for MedTech startups, especially when it comes to medical device cybersecurity and regulatory compliance. He emphasizes the importance of deeply understanding customer needs and th
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In this essential episode of The Med Device Cyber Podcast, hosts Trevor Slattery and Christian Espinosa, joined by special guest Jake Rodriguez of Triangle Tech, delve into the burgeoning role of AI in medical device cybersecurity, marketing, and software development. The discuss
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Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act. The FDA's 2026 cybersecurity guidance is direct: if your device meets the "cyber device" threshold, you must demonstrate reasonable assurance of cyber
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What are the cybersecurity risks of legacy medical devices in hospitals? It's a question more hospital security teams are asking, and not finding easy answers to. Hospitals operate some of the most sophisticated care environments in the world: robotic surgery systems, real-time patient monitoring ne
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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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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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Neurotech cybersecurity risks affect therapy and neural data. Learn threats, controls, and FDA-ready documentation for neurostimulators, EEG, and BCI.
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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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Cybersecurity is the overlooked threat in medtech. Discover how Blue Goat Cyber helps founders avoid FDA delays, protect patients, and win investor trust.
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Learn how MedTech innovators can turn cybersecurity into a competitive advantage. Avoid FDA delays, build trust, and accelerate time-to-market.
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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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