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Webinar: Why FDA Cybersecurity Submissions Fail and How to Get Yours Approved
Medtech innovators and medical device manufacturers, how can you prevent cybersecurity deficiencies from delaying your FDA submission?
In this webinar, Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, reveal the most common reasons FDA cybersecurity submissions fail and how you can avoid them. They explain the importance of early risk management, security-by-design practices, and comprehensive testing aligned with NIST and AAMI frameworks.
Explored in this webinar:
00:37 Why poor cybersecurity is a top reason for FDA medical device rejection.
02:56 The FDA’s total product lifecycle approach.
05:18 Why risk management must start before design.
07:35 How AAMI TR57 and ISO 14971 interact to assess patient harm.
10:51 The FDA requirement for traceability among functional, nonfunctional, and security requirements.
16:16 Why cybersecurity testing must cover the entire product (mobile, cloud, etc.).
23:33 Why inadequate documentation for critical controls (authentication, logging, encryption) often causes FDA deficiencies.
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/
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.
Subscribe via Spotify: https://spoti.fi/3XX95g0
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
This was produced by Story On Media: https://www.storyon.co/
View all episodes
By Blue Goat CyberMedtech innovators and medical device manufacturers, how can you prevent cybersecurity deficiencies from delaying your FDA submission?
In this webinar, Christian Espinosa, CEO of Blue Goat Cyber, and Trevor Slattery, CTO of Blue Goat Cyber, reveal the most common reasons FDA cybersecurity submissions fail and how you can avoid them. They explain the importance of early risk management, security-by-design practices, and comprehensive testing aligned with NIST and AAMI frameworks.
Explored in this webinar:
00:37 Why poor cybersecurity is a top reason for FDA medical device rejection.
02:56 The FDA’s total product lifecycle approach.
05:18 Why risk management must start before design.
07:35 How AAMI TR57 and ISO 14971 interact to assess patient harm.
10:51 The FDA requirement for traceability among functional, nonfunctional, and security requirements.
16:16 Why cybersecurity testing must cover the entire product (mobile, cloud, etc.).
23:33 Why inadequate documentation for critical controls (authentication, logging, encryption) often causes FDA deficiencies.
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/
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.
Subscribe via Spotify: https://spoti.fi/3XX95g0
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
This was produced by Story On Media: https://www.storyon.co/