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.
Cybersecurity package delivered by senior US-based engineers.
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
Christian Espinosa, Founder & CEO, Blue Goat Cyber
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.
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.
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.
Onsite at your office or innovation center anywhere in the continental US. Virtual sessions available worldwide. Secure, non-recorded.
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
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 callWant a head start? These resources mirror what we'll walk through in the briefing.
What Section 524B actually requires and how reviewers are interpreting it.
Read FDA cybersecurity requirements (2026)The threat modeling approach that survives FDA review.
Read STRIDE threat modeling for medical devicesEvery artifact reviewers expect, in submission order.
Read FDA premarket cybersecurity submission checklistWhat 'ready for postmarket' looks like before you ship.
Read Postmarket cybersecurity readiness planHow we structure FDA-aligned testing across hardware, firmware, and apps.
Read Medical device penetration testingSDVOSB medical device cybersecurity firm. 275+ FDA submissions supported, zero cybersecurity rejections.
Read About Blue Goat Cyber30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
