Latest / The Med Device Cyber Podcast
FDA Cybersecurity Gets Real with Monica Montañez of NAMSA
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
* The confusion around FDA’s…
The skinny
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