How can you integrate relevant cybersecurity standards early in your medical device development process? Also, how do FDA cybersecurity standards help reduce the time to market for new medical devices?
In this episode, Trevor Slattery, CTO of Blue Goat Cyber, and Jordan John, Director of Regulatory Affairs and Compliance at Blue Goat Cyber, explore:
* The importance of integrating standards into the QMS from the start.
* How TIR57 complements ISO 14971 for security risk management.
* Why cybersecurity must be operational, not just documented.
* IEC 62304 and its role in secure software lifecycle processes.
* ISO/IEC 81001-5-1 is covered as a framework for secure product development.
* NIST SP 800-115 is explored as a guide for FDA-compliant penetration testing.
* How FDA guidance ties all the standards together.
This episode was 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 on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber
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
The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast.
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