MedTech manufacturers, how prepared are you to monitor vulnerabilities continuously once your medical device reaches the market? Also, would you like a free checklist for your Cybersecurity Management Plan? (See link below!)
This webinar dives into how medical device manufacturers should build, maintain, and document postmarket cybersecurity programs that align with FDA expectations. Christian and Trevor outline critical requirements such as continuous SBOM monitoring, testing timelines, update processes, CVD workflows, and secure communication standards.
Topics explored:
(03:14) How the FDA's definition of "cyber device" includes devices with Wi-Fi, Bluetooth, USB, RFID, and NFC connectivity.
(05:19) Recent FDA guidance changes, including updated cybersecurity expectations.
(10:30) Cybersecurity management plan personnel: compliance officer, product owner, postmarket owner, and authorizing official.
(12:30) Static testing, SBOM analysis, penetration testing, and vulnerability assessments.
(17:50) Security testing expectations and frequencies.
(20:30) Patching, update processes, and remediation timelines.
Download your free Cybersecurity Management Plan Checklist: https://bluegoatcyber.com/wp-content/uploads/2025/09/Blue-Goat-Cyber-Postmarket-Management-Checklist.pdf
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 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/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
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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:
