https://bluegoatcyber.com/assets/LpMedicalDeviceCyber-D7ZkhQmh.js

1import{j as e,a3 as i}from"./index-BYbhg4ys.js";import{A as t}from"./AdLanding-pjjOXCsn.js";import{l as r}from"./pathway-compare-Dm-8l5eQ.js";import"./HubSpotMeetingEmbed-OOoPiSDT.js";import"./phone-BEuxaCt0.js";import"./rotate-ccw-D5SeRsA_.js";const l=()=>e.jsx(e.Fragment,{children:e.jsx(t,{slug:"medical-device-cybersecurity",seoTitle:"Medical Device Cybersecurity for FDA Submissions",seoDescription:"Senior US-based medical device cybersecurity team. 275+ FDA submissions, 0 cybersecurity rejections. Fixed-fee quote within 24 hours.",eyebrow:"Medical Device Cybersecurity",lastUpdated:"2026-06-27",h1:"Medical Device Cybersecurity Engineered for First-Cycle FDA Review",keywordPhrase:"Medical device cybersecurity services, premarket packages, pen testing, SBOM, threat modeling, and postmarket.",intro:"A senior US-based team owns the whole cybersecurity side of your FDA submission. Everything is built to Section 524B and the FDA February 2026 final premarket guidance.",urgency:"The FDA February 2026 final guidance is now the bar reviewers apply. Submissions still built to the prior guidance are drawing first-cycle deficiency letters.",includes:["FDA premarket cybersecurity packages","Medical device penetration testing","SBOM (SPDX or CycloneDX) with VEX","STRIDE threat modeling + risk assessment","Postmarket vulnerability + CVD program","Cybersecurity deficiency response support"],scopeTitle:"What we cover across the device lifecycle",scopeBullets:[{label:"Premarket submissions",body:"510(k), De Novo, and PMA cybersecurity sections delivered eSTAR-ready and mapped to Section 524B(b)(1) through (3)."},{label:"Penetration testing",body:"Device, cloud, mobile, and wireless attack surfaces tested by senior engineers. Findings mapped to your threat model with remediation tracking."},{label:"Threat modeling",body:"End-to-end STRIDE threat model with multi-patient harm, updateability, and use-environment views. Aligned to ANSI/AAMI SW96, with AAMI TIR57 as the implementation guide."},{label:"SBOM + VEX",body:"Machine-readable SPDX or CycloneDX SBOM with NTIA minimum elements (now stewarded by CISA), support-end dates, and a VEX statement for every CVE in your shipping configuration."},{label:"Postmarket + CVD",body:"Vulnerability monitoring sources, severity-based response timelines, coordinated vulnerability disclosure policy, and patch delivery aligned to 524B(b)(1)."},{label:"Deficiency response",body:"Hold letters, refuse-to-accept, and AI cybersecurity deficiency letters. Point-by-point reviewer-ready responses in days, not weeks."}],pathwayCompare:r(),timeline:[{step:"Day 0",label:"Mutual NDA signed, then a 30-minute call with a senior engineer",body:"We sign a mutual NDA, then a senior medical device cybersecurity engineer walks your device, submission stage, and the cybersecurity evidence the FDA reviewer will expect."},{step:"Day 1",label:"Point-by-point gap list + fixed-fee quote",body:"Point-by-point gap list against Section 524B and the FDA February 2026 final guidance, each gap mapped to the artifact that closes it, with a fixed-fee quote covering every deliverable."},{step:"Weeks 2-8",label:"eSTAR-ready cybersecurity package",body:"Secure Product Development Framework (SPDF), SBOM with VEX, threat model, pen test, postmarket plan, and cybersecurity labeling. Delivered reviewer-format with unlimited revisions."}],faqs:[{q:"Which submission types do you cover?",a:"510(k), De Novo, and PMA. Every cybersecurity deliverable ships eSTAR-ready and mapped to Section 524B(b)(1)-(3)."},{q:"Are you already aligned to the FDA February 2026 final guidance?",a:"Yes. Every package we write today is built against the February 2026 final guidance, including the multi-patient harm view, VEX expectations, and patch delivery documentation."},{q:"Do you sign an NDA before the first call?",a:"Yes. Mutual NDA before the 30-minute call so you can share architecture, design history, and any FDA correspondence freely."},{q:"What happens on the free discovery call?",a:"30 minutes with a senior medical device cybersecurity engineer. We walk your architecture against Section 524B and the FDA February 2026 final guidance, flag where reviewers tend to hit you, and follow up with a fixed-fee quote within 24 hours."},{q:"Are your engineers US-based?",a:"Yes. Senior US-based medical device cybersecurity specialists own every FDA-facing deliverable. No offshoring."},{q:"What if the FDA still comes back with a cybersecurity deficiency?",a:"Fixed fee includes the response. We stay on the file until the cybersecurity portion is closed, including hold letters and follow-up exchanges."}],relatedResources:[{href:"/guides/fda-premarket-cybersecurity-submission-checklist",title:"FDA premarket cybersecurity submission checklist",kind:"Guide"},{href:"/guides/fda-524b-cybersecurity-requirements-explained",title:"Section 524B requirements, explained for engineers",kind:"Guide"},{href:"/guides/penetration-testing-for-medical-devices",title:"Penetration testing for medical devices: a 2026 explainer",kind:"Guide"}],testimonial:{quote:"Blue Goat Cyber helped us navigate our first end-to-e

1nd cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience.",attribution:"Anna Norman, VP of Product, InfoBionic.Ai"},primaryCta:"Book my free 30-min discovery call",formEyebrow:"Free 30-min discovery call",formHeading:"Pick a time. Talk to a senior expert.",formBlurb:"Grab 30 minutes with a senior medical device cybersecurity engineer. We'll walk your architecture, flag the gaps reviewers will hit under Section 524B and the FDA February 2026 final guidance, and tell you straight if you don't need us. Mutual NDA signed before the call.",ctaHeading:"See your gaps before the FDA reviewer does",ctaBlurb:"30-minute call with a senior medical device cybersecurity expert. Mutual NDA signed before the call. Fixed-fee quote within 24 hours of the call.",afterContent:e.jsx(i,{eyebrow:"Related deep dives",heading:"Read deeper on medical device cybersecurity",blurb:"Analysis and reference material on medtech threats, controls, lifecycle, and cybersecurity as strategy.",slugs:["traditional-cybersecurity-vs-medical-device-cybersecurity","the-rising-tide-of-cyber-threats-in-medical-devices-understanding-the-risks","what-are-the-most-concerning-medical-device-cyber-threats","cybersecurity-attack-entry-points-for-medical-devices","integrating-cybersecurity-assessments-into-the-medical-device-lifecycle","cybersecurity-practices-for-protecting-medical-devices-manufacturers-checklist"]})})});export{l as default};