What documents should engineers prepare to get ready for submitting a medical device to the FDA?

In this episode, Christian and Trevor dig into the underestimated role software documentation plays in cybersecurity, especially in the medical device space. They highlight how incomplete or contextless documentation can hinder everything from SBOM utility to regulatory compliance. With sharp insights and real-world examples, they make the case for elevating documentation as a strategic priority.

Key points:

(00:43) The Real Purpose of Documentation

* Software documentation is often seen as a checklist item rather than a strategic tool.

* Good documentation enables continuity and reduces knowledge silos.

(07:04) Security Starts with Documentation

* A lack of context in software can undermine their usefulness for vulnerability management.

* Documentation quality links with product security posture and incident response readiness.

(13:41) Regulation and Standards for Medical Device Documentation

* Documentation shouldn’t only meet minimum regulatory requirements.

* Strong documentation supports faster and safer decision-making during audits or breaches.

(18:11) Best Practices

* Trevor lists areas where developers consistently miss documentation opportunities (e.g., deprecated functions, third-party code).

* Christian outlines how consistent, contextual documentation helps new team members come up to speed.

(23:59) FDA Requirements

* The hosts recommend integrating documentation into sprint planning and CI/CD pipelines.

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

If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session

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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This episode was produced by Story On Media: https://www.storyon.co/