How have medical device cybersecurity requirements changed since 2023, and what does this mean for your product development?
In this episode, Christian and Trevor welcome Monica Montañez from NAMSA to unpack the evolving landscape of FDA cybersecurity requirements. From new laws introduced in 2023 to the ambiguous language in FDA guidance, they dig into what it really takes to meet expectations for cyber device submissions.
(0:32) NAMSA and Industry Shifts
- Monica introduces NAMSA’s role in regulatory and quality consulting.
(5:12) FDA Guidance vs. Legal Mandate
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The confusion around FDA’s "recommended" language.
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How internet-connectivity defines cyber devices - including USB and Bluetooth.
(12:57) Classifications, Interfaces, and Testing Gaps
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The dangers of assuming interfaces are disabled.
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Why early cybersecurity design is now critical for approval.
(18:08) New Submission Expectations
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What’s now required in a submission: threat models, risk assessments, lifecycle documentation.
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Trevor explains how these requirements balloon documentation to hundreds of pages.
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
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Thanks to Monica Montañez for being on the show.
Learn more about Monica on NAMSA’s website:
https://namsa.com/expertise/team/monica-r-montanez/
Connect with Monica on LinkedIn: https://www.linkedin.com/in/monica-montanez-ms-rs-rac-cqa-4389336
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
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Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
Feedback? Questions? Contact: https://bluegoatcyber.com/contact/
Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
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