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    Monica Montañez

    Consultant
    NAMSA
    Monica Montañez is a consultant at NAMSA, a CRO offering consulting services for regulatory and quality. She provides insights into medical device cybersecurity regulations and the challenges manufacturers face with compliance.

    About Monica's appearance on the show

    Monica Montañez, Consultant at NAMSA, joined The Med Device Cyber Podcast to share field-tested perspective with our audience of medical device security engineers, regulatory leads, quality teams, and MedTech founders. Every guest we book has either personally led an FDA cybersecurity submission, shipped a connected device into clinical use, or worked the disclosure and remediation side of a real-world vulnerability - we don't run vendor pitches or keynote-style overviews.

    The Med Device Cyber Podcast is produced by Blue Goat Cyber, a specialist medical device cybersecurity firm whose hosts have walked submissions through FDA, ISO 14971 risk management, IEC 62304 software lifecycle expectations, and SBOM hygiene under the Refuse-to-Accept policy. The show exists so the lessons learned by people doing this work daily - guests like Monica - reach the next team that has to figure it out for the first time. If you're researching Monica Montañez for a hiring decision, an advisory call, or to invite them onto your own programme, the episodes below are the most current public record of how they think about the problem.

    Want to keep exploring? Browse all our guests, jump to the complete episode catalog, or check our FDA Premarket, Postmarket, and Threat Modeling topic hubs for related conversations.

    Frequently Asked Questions

    Quick answers drawn from this episode.

    • Monica Montañez is Consultant at NAMSA. Monica Montañez is a consultant at NAMSA, a CRO offering consulting services for regulatory and quality. She provides insights into medical device cybersecurity regulations and the challenges manufacturers face with compliance.

    • Monica Montañez appears on 1 episode of The Med Device Cyber Podcast: Episode 66 - "FDA Cybersecurity Gets Real with Monica Montañez of NAMSA | Ep. 30".

    • Across Monica's appearances, recurring topics include medical device cybersecurity, fda regulations, samd, ai/ml in medtech, and regulatory compliance. These conversations focus on practical medical device cybersecurity guidance for MedTech teams.

    • Since September 2023, FDA cybersecurity guidelines for medical devices are no longer just recommendations but are legally enforceable under the FDORA legislation, giving the FDA the authority to reject submissions.

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