Medical Device Cybersecurity Executive Briefing — Complimentary 2-Hour Session
Onsite or virtual. Complimentary for qualified mid-to-large medical device manufacturers and strategics. One hour for executives, one hour for the engineers and RA/QA teams who do the work.
Length
2 hours, split agenda
Delivery
Onsite or virtual
Cost
Complimentary for qualified manufacturers
Why we offer this
Raising the floor of medical device cybersecurity.
Patients deserve safer connected devices, and manufacturers deserve to understand the FDA's expectations without having to sign a contract first. Part of our mission is to share what we've learned across 250+ FDA cybersecurity submissions so that more devices ship secure, on time, and with confidence. This briefing is one of the ways we do that.
Hour 1 - Executive session
Strategy, risk, and FDA reality
For VP Product, VP RA/QA, CTO, CISO, and product GMs. Plain-English framing of where the regulatory bar is moving and what it means for roadmap and risk.
- Section 524B and 2026 FDA cybersecurity expectations - what reviewers actually flag.
- Where late cybersecurity engagement quietly costs months of submission time.
- Postmarket obligations: SBOM, CVD, monitoring, and patch responsibilities.
- Board-ready framing of patient safety, brand, and litigation exposure.
- Open Q&A on the team's specific portfolio risks.
Hour 2 - Technical deep-dive
Engineering and RA/QA working session
For software, firmware, security, and RA/QA engineers. Practical, hands-on framing of what good looks like and where most teams stumble.
- Threat modeling that reviewers accept (STRIDE, AAMI SW96/TIR57 alignment).
- SBOMs that survive FDA scrutiny: SPDX/CycloneDX, VEX, and CVE/KEV mapping.
- Penetration testing scope, evidence, and findings format the FDA expects.
- Common eSTAR and deficiency-letter root causes - and how to avoid them.
- Questions on the team's specific architecture, protocols, or submission.
Who it's for
Mid-to-large medical device manufacturers and strategic acquirers shipping connected devices, SaMD, or AI/ML-enabled products.
Where we deliver it
Onsite at your office or innovation center anywhere in the continental US. Virtual sessions available worldwide.
What you walk away with
A shared internal vocabulary, a candid view of your current cybersecurity posture, and a one-page take-home of next steps - with no obligation.
Request a briefing
Tell us about your team.
We confirm qualification (mid-to-large MDM or strategic), align an agenda with your stakeholders, and propose dates within 5 business days.
Prefer to talk first? We'll confirm fit and pick a format that works for your team.
Topics we'll cover - and pages your team can read first
Want a head start? These resources mirror what we'll walk through in the briefing.
FDA cybersecurity requirements (2026)
What Section 524B actually requires and how reviewers are interpreting it.
Learn moreSTRIDE threat modeling for medical devices
The threat modeling approach that survives FDA review.
Learn moreFDA premarket cybersecurity submission checklist
Every artifact reviewers expect, in submission order.
Learn morePostmarket cybersecurity readiness plan
What 'ready for postmarket' looks like before you ship.
Learn moreMedical device penetration testing
How we structure FDA-aligned testing across hardware, firmware, and apps.
Learn moreAbout Blue Goat Cyber
SDVOSB medical device cybersecurity firm - 250+ FDA submissions, zero rejections.
Learn moreGet FDA cleared without the cybersecurity headaches.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.