Cybersprint™ Program

30-Day Cybersprint™ Program

Complete FDA cybersecurity documentation and testing without draining your team or getting bogged down in reviewer back-and-forth.

Book a 30-min call Check your readiness

What Our Clients Walk Away With

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

Program Overview

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.

How We Deliver

A two-phase process combining deep technical expertise, proven systems, and direct support from our cybersecurity, software, and regulatory leads.

Phase I: Establish a Clear Cybersecurity Architecture

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

Security Architecture Views
Threat Model
Cybersecurity Risk Assessment
Cybersecurity Controls Matrix
Draft: Safety & Security Assessment of Cybersecurity Vulnerabilities
Cybersecurity Management Plan
Preliminary Cybersecurity Test Plan & Protocol

These deliverables lay the foundation for your entire submission, bringing immediate structure and clarity to your team.

Phase II: Execute Testing & Final Documentation

After the architecture documents are finalized, we shift into full execution. We prepare every remaining artifact and complete cybersecurity testing.

Phase deliverables

Updated Architecture Documents (if needed)
SBOM Analysis
Software Level of Support Documentation
Assessment of Unresolved Anomalies for Cybersecurity Impact
Fuzz and Penetration Testing
Cybersecurity Test Report
Final Safety & Security Assessment of Cybersecurity Vulnerabilities
Cybersecurity Metrics Report
Cybersecurity Summary Report
Customized eSTAR Checklist mapping every document to the right submission location

We meet with your team at critical checkpoints, guide decisions, and adapt as needed. You stay on track for submission without surprises.

What You Get

14 FDA cybersecurity deliverables, complete documentation and testing aligned with regulatory expectations
Fuzz and penetration testing led by our Chief Security Officer with 35+ years of experience in high-security systems
Customized eSTAR checklist so you know exactly where every document belongs in your submission
Reviewer response support at no extra cost if the FDA has questions
Post-market plan that prepares you for real-world compliance after launch

Our Guarantee

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.

Why Teams Trust Us

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.

Who This Is For (and Not For)

This is a great fit if:

You're preparing a 510(k) and your product includes software
You've completed your architecture and software requirements, or want our help doing so
You value a secure, compliant submission and want to get it right the first time
You're ready to move quickly and appreciate clear, collaborative execution

This probably isn't for you if:

You haven't defined your system architecture or software requirements yet (our Software DHF Program can help create those drafts under an FDA-compliant process)
You're not ready to engage in reviews or respond to requests from our team
You're looking for a checkbox exercise. We focus on real security and real compliance.

Next Steps

If this sounds like the right fit for your team:

Send us a message that says "Let's get started." (or click the button below)
We schedule a call to review your goals and timeline
Reserve your slot in the Cybersprint
Sign a simple Statement of Work with mutual NDA language
Share any software/DHF documentation you already have
Kick off the sprint and begin the 30-day execution

Book a 30-min call Check your readiness

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.

Results

"FDA came back with zero cybersecurity issues. That saved us months."

VP of Regulatory Affairs, Axena Health

"Their documentation was extremely thorough. We couldn't be happier."

CTO, Innovation Zed

"They identified a serious vulnerability and helped us fix it. Our submission is now stronger and our product more secure."

Lead Engineer, Hexoskin

Our Team Includes

A PhD engineer from MIT with 20+ years of medical device experience
A Chief Security Officer who has built secure systems for nuclear submarines, nation-state security agencies, Fortune 500 networks, and medical devices
Seasoned software and security architects ready to roll up their sleeves

You're not hiring a vendor. You're partnering with specialists trusted to protect lives, infrastructure, and data at the highest levels.

FAQ

›How long does the program actually take?

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.

›What artifacts do we get at the end?

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.

›What's the scope? Does this cover our entire submission?

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.

›Will we be ready for submission after 30 days?

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.

›How much work does our team need to do?

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.

›What if we haven't finished our software documentation yet?

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.

›Can't our engineering team just write this documentation themselves?

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.

›We're planning to submit in 2-3 months. Is that too soon?

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.

›What happens if the FDA comes back with questions?

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.

›How do we know you're qualified to do this?

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 where you stand?

Not sure if you're ready? Reach out and we'll help you figure out where you stand.

Check your readiness

Looking forward to working with you,

Jose Bohorquez, PhD
President, CyberMed