Complete FDA cybersecurity documentation and testing without draining your team or getting bogged down in reviewer back-and-forth.
Need penetration testing specifically?
If your immediate need is testing scope, evidence, and remediation planning, start with the dedicated penetration-testing path. It explains what testing can cover, what deliverables to expect, and how the work fits into cybersecurity documentation.
Practical checklist
Prepare architecture context, scope boundaries, access plans, and evidence expectations before a medical device penetration test starts.
We'll send the checklist to your inbox after a quick confirmation.
Zero cybersecurity deficiencies
on FDA review for our most recent Cybersprint client
14 deliverables in 30 days
complete documentation and testing package, ready for eSTAR submission
35+ years security experience
our CSO has built secure systems for nuclear submarines, nation-state agencies, and Fortune 500 networks
Response support included
if FDA flags any cybersecurity item we prepared, we revise and respond at no extra cost
The outcome is simple: deliver a complete, FDA-ready cybersecurity documentation and testing package in 30 days, without burning internal capacity, risking delays, or getting stuck in review cycles.
We're partnering with a small group of medical device teams preparing for submission to help them cross the finish line. Secure, compliant, and ready to launch.
A two-phase process combining deep technical expertise, proven systems, and direct support from our cybersecurity, software, and regulatory leads.
We start with a kickoff session to review your current documentation and technical approach. Within the first 2-3 weeks, we deliver the core architecture-phase documents aligned with FDA expectations.
Phase deliverables
These deliverables lay the foundation for your entire submission, bringing immediate structure and clarity to your team.
After the architecture documents are finalized, we shift into full execution. We prepare every remaining artifact and complete cybersecurity testing.
Phase deliverables
We meet with your team at critical checkpoints, guide decisions, and adapt as needed. You stay on track for submission without surprises.
If the FDA flags any cybersecurity item we prepared, we'll revise the documentation and help draft the response at no additional cost.
If your team makes changes that require retesting, we'll provide it at a deep discount. Our job isn't done until your submission clears.
Engineering depth
Our founder holds a PhD from MIT and has led medical device development for over 20 years.
Security pedigree
Our CSO spent decades building secure systems in environments where failure wasn't an option: submarines, intelligence agencies, critical infrastructure.
Process transparency
You see every deliverable as it's built. No black boxes. Weekly checkpoints, shared review folders, and direct access to the team doing the work.
Delivery confidence
We've taken teams from multi-deficiency rejections to clean, reviewer-approved submissions. We know what FDA expects because we've been through it.
If this sounds like the right fit for your team:
Bonus
When you sign up, request a complimentary Software DHF Gap Analysis (a $5,000 value). We'll audit your software documentation and flag gaps that could derail cybersecurity review.
"FDA came back with zero cybersecurity issues. That saved us months."
"Their documentation was extremely thorough. We couldn't be happier."
"They identified a serious vulnerability and helped us fix it. Our submission is now stronger and our product more secure."
You're not hiring a vendor. You're partnering with specialists trusted to protect lives, infrastructure, and data at the highest levels.
30 days from kickoff to final deliverables. We've run this process enough to know the pace, and we build buffer into our schedule for review cycles.
If your situation requires a faster turnaround, we can discuss expedited timelines during the initial call.
You get 14 complete FDA cybersecurity deliverables: architecture documents, threat model, risk assessment, controls matrix, SBOM analysis, fuzz and pen test reports, the cybersecurity summary report, and a customized eSTAR checklist that maps every document to the right submission location.
All deliverables are yours to keep and submit.
Cybersprint covers the full cybersecurity portion of your FDA submission. It does not cover software DHF, general design controls, or clinical documentation.
If you also need software documentation, ask about our Software DHF program. We can run them in parallel or sequence them.
For the cybersecurity portion, yes. You'll have a complete, reviewer-ready package with every document mapped to the eSTAR checklist.
If any other parts of your submission need work, we can help you identify gaps early.
We do the heavy lifting. Your team's job is to show up at weekly checkpoints, answer questions about your system, and review deliverables as they come in.
Plan for about 2-4 hours per week of your engineering team's time. We handle the rest.
That's not a problem. If your system architecture or software requirements aren't complete, we can help prepare them under a separate program before the Cybersprint begins.
You don't need a perfect DHF to start the conversation. We can meet you where you are.
They can try, but FDA cybersecurity documentation is specialized, time-intensive work.
Our team has spent decades in high-security environments and understands how reviewers evaluate these materials. We help you avoid the rewrite cycles that drain momentum.
The sooner you start, the better. Ideally, cybersecurity work begins before your software is fully complete.
If your device is nearly done and you're targeting a submission within 2-3 months, we can still help. Cybersprint is designed for a 30-day turnaround, and we can explore expedited paths if needed.
We're still in your corner. If the FDA flags any cybersecurity item we prepared, we'll revise the documentation and help draft your response at no extra cost.
Our founder holds a PhD in engineering and computer science from MIT and has led medical device development for over 20 years.
Our Chief Security Officer has 35+ years building secure systems for some of the world's most demanding environments.
We've helped teams move from multi-deficiency rejections to clean, reviewer-approved submissions.
Not sure if you're ready? Reach out and we'll help you figure out where you stand.
Check your readinessLooking forward to working with you,
Jose Bohorquez, PhD
President, CyberMed