Cybersecurity Qs MedTech Innovators Ask: Christian’s Hot Seat | Ep. 48 скачать в хорошем качестве

Cybersecurity Qs MedTech Innovators Ask: Christian’s Hot Seat | Ep. 48

MedTech manufacturers, how can you avoid the cybersecurity pitfalls that most often lead to FDA rejection? In this episode, Trevor puts Christian “in the hot seat” to tackle the most common—and sometimes misunderstood—cybersecurity questions MedTech innovators ask. Christian breaks down key concepts such as ISO 13485, HIPAA vs. FDA expectations, SAMD vs. SIMD, global regulatory demands, and more. Key points: (00:30) The purpose of ISO 13485 and why traceability, quality, and documentation are foundational to medical device safety. (02:34) How cybersecurity is now the most common reason FDA reviewers reject medical devices. (04:32) Why HIPAA focuses on patient data while the FDA focuses on patient safety. (07:21) Which global regulators impose the strictest cybersecurity requirements and how FDA and China differ. 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-goa... 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:   / christianespinosa   Blue Goat Cyber on LinkedIn:   / blue-goat-cyber   Blue Goat Cyber on Instagram:   / bluegoatcyber   Blue Goat Cyber on Facebook:   / bluegoatcyber   Blue Goat Cyber on YouTube:    / @bluegoatcyber   Trevor Slattery on LinkedIn:   / 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:    / @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://open.spotify.com/show/5ol62RO... Subscribe via Apple Podcasts: https://apple.co/483OJ9I Subscribe via YouTube:    / @bluegoatcyber