CyberMed
Cybersprint™ Program

The complete FDA cybersecurity package, delivered in 30 days.

For teams with a submission date and no cybersecurity file yet. Fourteen deliverables, fixed price, written for the reviewer. If FDA asks about anything we prepared, we answer it at no extra cost.

The Cybersprint is CyberMed's fixed-scope program that produces the complete FDA cybersecurity package for a 510(k), De Novo, or PMA in 30 days: threat model, security risk assessment, SBOM, architecture views, controls and verification, penetration test evidence, labeling, and the postmarket management plan. It covers what Section 524B and FDA's premarket cybersecurity guidance ask for in the eSTAR.

By Jose Bohorquez, PhD, President · Updated

Book a callCheck your cyber readiness

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.

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.

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.

Ready to start?

  1. Book a call. We review your device, submission path, and timeline.
  2. Sign a short statement of work with mutual NDA language.
  3. Share whatever documentation you already have, and we kick off within days.
Book a callCheck your cyber readiness

Looking forward to working with you,

Jose Bohorquez, PhD
President, CyberMed