FDA Cybersecurity & Strategic Risk for MedTech Leadership
A private, two-hour working session. Complimentary. Onsite or virtual. No pitch deck.
For VP Product, VP RA/QA, CTO, and CISO at $100M–$2B medical device manufacturers shipping connected devices, SaMD, or AI/ML-enabled products into the FDA's evolving cybersecurity regime.
Tailor this briefing for
Reserved for qualified manufacturers & strategic acquirers
FDA submissions supported across Class II & Class III devices.
FDA submission acceptance rate on cybersecurity. Zero cyber rejections.
MedTech World NA, Medical Device Cybersecurity Partner of the Year.
Length
Two hours, split agenda
Delivery
Onsite or virtual
Cost
Complimentary, qualified firms
Why we offer this
"Mid-cap and strategic manufacturers deserve a candid read on the FDA's cybersecurity bar , without signing a contract first. We share what we've learned across 250+ submissions so more devices ship secure, on time, and with confidence."
Christian Espinosa, Founder & CEO, Blue Goat Cyber
The Two-Hour Briefing Structure · Tailored for Mid-cap manufacturers
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, headcount, and risk.
- Section 524B and the FDA's 2026 final premarket cybersecurity guidance: what reviewers actually flag.
- Where late cybersecurity engagement quietly costs months of submission time, and how to budget for it.
- Postmarket obligations: SBOM, CVD, monitoring, and patch responsibilities your QMS must now own.
- Board-ready framing of patient safety, brand, and litigation exposure for a growth-stage MedTech.
- Open Q&A on your portfolio's specific risks and upcoming submissions.
Engineering and RA/QA working session
For software, firmware, security, and RA/QA engineers. Practical framing of what good looks like and where mid-cap teams most often stumble at submission time.
- Threat modeling 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 your specific architecture, protocols, or in-flight submission.
Who it's for
Mid-cap medical device manufacturers ($100M–$2B) shipping connected devices, SaMD, or AI/ML-enabled products. VP Product, VP RA/QA, CTO, CISO, and senior engineering leadership.
Where we deliver it
Onsite at your office or innovation center anywhere in the continental US. Virtual sessions available worldwide. Secure, non-recorded.
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 acquirer), align an agenda with your stakeholders, and propose dates within 5 business days.
Prefer to talk first? Book a 20-minute scoping call to confirm fit.
Book scoping callTopics 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.
Read FDA cybersecurity requirements (2026)STRIDE threat modeling for medical devices
The threat modeling approach that survives FDA review.
Read STRIDE threat modeling for medical devicesFDA premarket cybersecurity submission checklist
Every artifact reviewers expect, in submission order.
Read FDA premarket cybersecurity submission checklistPostmarket cybersecurity readiness plan
What 'ready for postmarket' looks like before you ship.
Read Postmarket cybersecurity readiness planMedical device penetration testing
How we structure FDA-aligned testing across hardware, firmware, and apps.
Read Medical device penetration testingAbout Blue Goat Cyber
SDVOSB medical device cybersecurity firm - 250+, zero cyber rejections.
Read About Blue Goat CyberGet FDA cleared without the cybersecurity headaches.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.