Will Your Pentest Report Pass FDA Review?
30% of 510(k) submissions were flagged for inadequate penetration testing documentation in 2024. Complete the interactive checklist below to find your gaps before the FDA does.
Email me my checklist results when I'm done.
Tick each item your current pentest report meets. Your readiness score will appear here.
SECTION 01 / 03 — TESTER INDEPENDENCE
SECTION 02 / 03 — TEST METHODOLOGY & COVERAGE
Most commercial pentest reports fail sections 2 and 3. If you're uncertain about any of these items, your current report likely has gaps that will trigger an FDA deficiency request. Get a free gap review.
SECTION 03 / 03 — REPORT & SUBMISSION READINESS
Your readiness score will appear here as you complete the checklist.
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What Happens After You Submit
We Review in 24 Hours
A senior FDA pentest specialist reviews your submission and your checklist results.
You Get an Honest Assessment
We tell you exactly where your documentation stands, no sales pressure, no pitch.
Fix It Before You Submit
If there are gaps, we scope a targeted engagement to close them before your 510(k) review.
Our Team
Our Hackers Are Certified Professionals
Every engagement is led by senior, US-based ethical hackers with elite certifications and deep domain expertise.
US Based Testers
All penetration testers are based in the United States, ensuring compliance with data residency and regulatory requirements.
Senior Level Only
We only staff senior penetration testers with 5+ years of hands-on offensive security experience. No juniors, no outsourcing.
Hyper-Specialized Experts
Each tester is deeply specialized in their domain, from web apps and APIs to hardware, SCADA, wireless, and medical devices.
Certifications Held by Our Team
OSCP
Offensive Security Certified Professional
OSCE³
Offensive Security Certified Expert
OSWE
Offensive Security Web Expert
OSEP
Offensive Security Experienced Pentester
CRTO
Certified Red Team Operator
CRTP
Certified Red Team Professional
CEH
Certified Ethical Hacker
GPEN
GIAC Penetration Tester
GWAPT
GIAC Web App Penetration Tester
CISSP
Certified Information Systems Security Professional
CPTS
Certified Penetration Testing Specialist
eWPT
eLearnSecurity Web Pentester