60-Day Cybersprint™ Program
Complete FDA cybersecurity documentation and testing
Only 3 spots left for July!
Program Overview
The outcome is simple: to deliver a complete, FDA-ready cybersecurity documentation and testing package in 60 days, without draining your internal team, risking delays, or getting caught in back-and-forth with reviewers.
We’re selecting a small group of medical device companies preparing for FDA submission to help them cross the finish line—secure, compliant, and ready to launch.
How We Deliver
We use a two-phase process that combines deep technical expertise, proven systems, and direct support from our cybersecurity, software, and regulatory teams.
Phase I: Establish a Clear Cybersecurity Architecture
We start with a kickoff meeting to review your current documentation and technical approach. Within the first 2–3 weeks, we’ll deliver your core architecture-phase documents—developed to FDA expectations and aligned with your system.
Phase I 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 internal team.
Phase II: Execute Testing & Final Documentation
Once we finalize the architecture-phase documentation, we move into full execution mode, preparing every remaining artifact and completing cybersecurity testing.
Phase II 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 for mapping every document to the correct submission location
We’ll meet with your team at critical checkpoints, guide you through decisions, and adapt as needed, always with the goal of getting you to submission without surprises or delays.
What You Get
- 14 FDA Cybersecurity Deliverables – Complete documentation and testing, aligned with regulatory expectations
- Fuzz and Penetration Testing – Performed by a team led by our Chief Security Officer with over 35 years of experience in high-security systems
- Customized eSTAR Checklist – Know exactly where each document belongs in your submission
- Reviewer Response Support – If the FDA has questions, we’ll help you respond—at no extra cost
- Post-Market Plan – A cybersecurity management plan designed not just for submission, but for real-world compliance after launch
Cost and Payment Plan
The cost depends on your system, but we can quote it after just one call. Payments are milestone-based to ensure we’re fully aligned with your success.
| 25% | Deposit to reserve your spot |
| 25% | After architecture documents are complete |
| 25% | After final documentation and testing |
| 25% | Only after FDA 510(k) clearance |
Our Guarantee
If the FDA flags any cybersecurity item we prepared, we’ll revise the documentation and help draft the response, at no extra cost.
If your team makes changes that require retesting, we’ll provide up to two full rounds of retesting included in the program.
Our job isn’t done until your submission clears.
Who This Is For (And Not For)
This is a great fit for you 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 is not for you if:
- You haven’t yet defined your system architecture or software requirements (However, this may be the perfect time for our Software DHF Program, where we prepare drafts of your foundational documentation under an FDA-compliant process.)
- You’re not ready to engage with key reviews or respond to our requests
- You’re looking for a generic, checkbox-style shortcut. We’re here to build real compliance and real security
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’ll schedule a quick call to review your goals and timeline
- We’ll reserve your slot in the Cybersprint
- We’ll sign a simple Statement of Work with mutual NDA language
- You’ll send us any software/DHF documentation you’ve already completed
- We’ll schedule your kickoff meeting and begin your 60-day sprint
Bonus
When you sign up, we’ll perform a Software DHF Gap Analysis—a $3,000 value, included at no additional cost.
We’ll review your existing software documentation and flag any gaps or weaknesses that could cause problems during cybersecurity evaluation or FDA review.
Results
We’ve helped multiple medical device teams avoid costly delays, secure clean clearances, and launch faster, with confidence.
“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.”
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, and global Fortune 500 networks… and many medical devices
- Seasoned software and security architects ready to roll up their sleeves
You’re not just hiring a vendor—you’re partnering with a team that’s been trusted to protect lives, infrastructure, and data at the highest levels.
FAQ
That’s not a problem. If your system architecture or software requirements aren’t complete yet, we can help you prepare those 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 cybersecurity documentation for FDA is a specialized, evolving area. Most engineering teams don’t have the regulatory experience or time to get it right, and mistakes often result in months of costly delays. Our team lives and breathes this process. We’ll get it done faster, cleaner, and with far less disruption.
Yes. FDA’s cybersecurity expectations apply to any medical device that includes software—regardless of connectivity. Even basic embedded systems require threat modeling, risk assessment, testing, and lifecycle controls. It’s not about whether you’re online—it’s about whether you have software.
We can’t control FDA decisions—but we can guarantee that your cybersecurity submission will be complete, defensible, and aligned with current FDA expectations. We’ve helped clients recover from 14-deficiency letters and go on to receive zero cybersecurity comments in their resubmissions. And we include post-submission support at no extra charge—because we stand behind our work.
We expect iteration. That’s why we include up to two full rounds of retesting (fuzz and penetration) at no additional cost. You can move forward with confidence, knowing the process won’t break if something needs to change.
What you can’t afford is a cybersecurity deficiency that delays your clearance by 3 to 9 months—costing you time, momentum, and funding opportunities.
Our milestone-based payment plan spreads your investment across key deliverables, including a final 25% that’s not due until your device is cleared. It’s structured to support cash flow and keep your submission on track.
Very little. We lead the process and do the heavy lifting. Your team will participate in a few short meetings, review draft documents, and provide key inputs. Most clients spend less than 10 hours total with us over the 60-day sprint.
The sooner you start, the better. Ideally, you begin cybersecurity work before your software is fully implemented.
That said, if your device is nearly complete and you’re targeting submission in the next 2–3 months, we can absolutely help. Our Cybersprint is designed to deliver in 60 days, and if your timeline is tighter, we’re happy to explore an expedited path.
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. You won’t be left scrambling.
We bring decades of experience on both the engineering and regulatory sides.
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 spent 35+ years building secure systems for nuclear submarines, nation-state security agencies, and Fortune 500 infrastructure.
We’ve helped teams move from multi-deficiency rejections to clean, reviewer-approved submissions—and we can do the same for you.
Looking forward to working with you,
Jose Bohorquez, PhD
President, CyberMed
P.S. We only take on 5 Cybersprint clients per month, and only 3 slots remain for July.
If you’re planning to submit this quarter (or align with a funding milestone), reach out now to reserve your spot.