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    Mark Swanson

    Partner
    QRX Partners
    Mark Swanson is a partner at QRX Partners, focused on quality and regulatory for medical devices. He has experience working with both large and small companies, and he and his partner also teach at St. Cloud State University.

    About Mark's appearance on the show

    Mark Swanson, Partner at QRX Partners, 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 Mark - reach the next team that has to figure it out for the first time. If you're researching Mark Swanson 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.

    • Mark Swanson is Partner at QRX Partners. Mark Swanson is a partner at QRX Partners, focused on quality and regulatory for medical devices. He has experience working with both large and small companies, and he and his partner also teach at St. Cloud State University.

    • Mark Swanson appears on 1 episode of The Med Device Cyber Podcast: Episode 16 - "From Concept to Compliance: A Guide to Med Device Approval | Ep. 24".

    • Across Mark's appearances, recurring topics include medical device regulation, quality management system (qms), fda compliance, medtech startups, and cybersecurity. These conversations focus on practical medical device cybersecurity guidance for MedTech teams.

    • Early-stage medical device companies often underestimate the time and money required for regulatory approval, a primary reason for the high failure rate in the industry.

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