--- title: "Medical Device Cybersecurity: The Book" description: "Medical Device Cybersecurity: The Book, the definitive playbook on FDA premarket submissions and postmarket surveillance, by Christian Espinosa. Coming 2026." lang: en json-ld: | [ { "@context": "https://schema.org", "@type": "Person", "@id": "https://christianespinosa.com/#person", "name": "Christian Espinosa", "url": "https://christianespinosa.com/", "image": "https://christianespinosa.com/__l5e/assets-v1/de07e44b-a8e0-4bcc-bcb0-13aec15421f1/headshot-front.jpg", "sameAs": [ "https://www.facebook.com/christian.espinosa.official", "https://x.com/Ironracer", "https://www.instagram.com/christian.espinosa.official/", "https://www.youtube.com/@ChristianEspinosaOfficial", "https://www.linkedin.com/in/christianespinosa/" ], "jobTitle": "Bestselling Author, Keynote Speaker, Entrepreneur", "worksFor": { "@type": "Organization", "name": "Blue Goat Cyber", "url": "https://bluegoatcyber.com/" } }, { "@context": "https://schema.org", "@type": "WebSite", "@id": "https://christianespinosa.com/#website", "name": "Christian Espinosa", "url": "https://christianespinosa.com/", "publisher": { "@id": "https://christianespinosa.com/#organization" }, "inLanguage": "en-US" }, { "@context": "https://schema.org", "@type": "Organization", "@id": "https://christianespinosa.com/#organization", "name": "Christian Espinosa", "url": "https://christianespinosa.com/", "logo": { "@type": "ImageObject", "url": "https://christianespinosa.com/logo.svg" }, "founder": { "@id": "https://christianespinosa.com/#person" }, "sameAs": [ "https://www.facebook.com/christian.espinosa.official", "https://x.com/Ironracer", "https://www.instagram.com/christian.espinosa.official/", "https://www.youtube.com/@ChristianEspinosaOfficial", "https://www.linkedin.com/in/christianespinosa/" ] }, { "@context": "https://schema.org", "@type": "Book", "name": "Medical Device Cybersecurity: The Book", "alternateName": "Navigating Premarket Submissions and Postmarket Surveillance", "author": { "@type": "Person", "name": "Christian Espinosa", "url": "https://christianespinosa.com/about" }, "inLanguage": "en", "datePublished": "2026", "image": "/__l5e/assets-v1/3d59bfc7-1c61-43c6-9b26-c6716b254511/mdc-cover.webp", "url": "https://christianespinosa.com/books/medical-device-cybersecurity", "publisher": { "@type": "Organization", "name": "Christian Espinosa" }, "description": "The definitive playbook for shipping safe, secure medical devices. Eleven chapters span the Total Product Lifecycle: regulatory landscape, risk management, Secure Product Development Frameworks, security architecture, interoperability, STRIDE threat modeling, SOUP analysis, cybersecurity testing, and structured risk assessment." } ] --- [Skip to content](#main) [](/) [About](/about)[Speaking](/speaking)[Cybersecurity](/cybersecurity)[Programs](/programs)[Books](/books)[Media](/media) Writing Search Ctrl K[Connect](/connect) ![Medical Device Cybersecurity: The Book by Christian Espinosa, cover](/__l5e/assets-v1/3d59bfc7-1c61-43c6-9b26-c6716b254511/mdc-cover.webp) Coming 2026 · In progress # Medical Device Cybersecurity. Navigating Premarket Submissions and Postmarket Surveillance A complete, working playbook for the teams responsible for shipping safe, secure medical devices. Eleven chapters span the Total Product Lifecycle, aligned with FDA's Feb 2026 final premarket cybersecurity guidance, plus EU MDR, PMDA, and NMPA. Every chapter closes with useful tips, key terms, and a real case study from the field. [Get launch notification](https://medicaldevicecybersecuritybook.com/#notify)[Read excerpts](https://medicaldevicecybersecuritybook.com/#excerpts)[Bulk orders for teams](/connect) - FDA 2026 - EU MDR - PMDA - NMPA - AAMI SW96 - ISO 14971 - STRIDE - SBOM - SOUP Chapter overview ## Eleven chapters across the Total Product Lifecycle. Written for the engineering, RA/QA, and product leaders who own the submission, the audit, and the postmarket response. - 01 ### Regulatory Landscape FDA, EU MDR, PMDA (Japan), NMPA (China), TGA (Australia), plus NIST, AAMI, and IEC mapped to one program. - 02 ### Risk Management & TPLC Building a cybersecurity risk management report that holds up across the Total Product Lifecycle, premarket through postmarket. - 03 ### Secure Product Development (SPDF) FDA-aligned development, security architecture views, and design controls that actually clear submission. - 04 ### Security Architecture Views Global system view, multi-patient harm view, updateability/patchability view, and interface views. - 05 ### Interoperability Connected device communication, integration with hospital networks, and the security implications of HL7/FHIR. - 06 ### STRIDE Threat Modeling Trust boundary analysis, entry point analysis, and threat scenario development with a worked STRIDE case study. - 07 ### Third-Party Software & SOUP Managing components, Software of Unknown Provenance, and SBOMs with a SOUP case study in medical imaging. - 08 ### Cybersecurity Testing Penetration testing, vulnerability scanning, fuzz testing, and software composition analysis for medical devices. - 09 ### Cybersecurity Risk Assessment Structured risk assessment, scoring, mitigation, and the security risk management report FDA expects. - 10 ### Postmarket Surveillance Vulnerability monitoring, coordinated disclosure, patch programs, and the postmarket cybersecurity management plan. - 11 ### Case Studies Philips Tasy EMR (2018), SaMD 510(k), wearable health monitoring, and remote patient monitoring testing. For teams shipping connected devices ## Want the team trained on this _now_? [Work with Blue Goat Cyber ↗](https://bluegoatcyber.com/)[Book a workshop](/speaking)[All books](/books) Christian Espinosa Bestselling author, keynote speaker, and Founding CEO of [Blue Goat Cyber](https://bluegoatcyber.com/). Helping technical leaders develop the soft skills that turn brilliance into impact. 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