Medical Device Cybersecurity
FDA cybersecurity requirements can hold up a submission when the evidence isn't there. Let us help you close those cybersecurity gaps in 30 days or less with cybersecurity testing, documentation, and FDA cybersecurity consulting. Move toward clearance without pulling your engineers away from product development.
Book a call and you'll talk to a security engineer, not a salesperson. Or take the three-minute readiness check, no account required.
Dozens of submissions supported. Zero cybersecurity rejections by FDA.Ask us about them on the call.
- ISO 13485 Certified
- U.S.-Based Team
What brought you here?
A submission is coming
Good news: Your 510(k), De Novo, or PMA is on the calendar, but the bad news is that the cybersecurity section of the eSTAR is blank or in bad shape.
FDA already asked
You probably didn't want to see this. An Additional Information letter showed up with cybersecurity deficiencies. That means the clock is running, and you need to address the issues without putting the submission at risk.
The device is already out there
Sooner or later someone asks who owns medical device cybersecurity after launch. Perhaps the SBOM is stale, or patch decisions happen ad hoc. This is not good. What do you do?
Here's what done looks like
The cybersecurity section clears on the first pass.
Congrats! Security architecture views, threat model, risk assessment, SBOM, and test reports the reviewer accepts without sending a deficiency round.
Your engineers never left the product.
We write, test, and package the evidence. Your team reviews it, signs it, and keeps building.
The launch date holds.
Cybersecurity stops being the line item that slips the quarter. The board never hears the word.
Teams that had FDA questions on the desk, and what happened next.
Cleared after FDA sent cybersecurity questions on an indication expansion.
“Our device was cleared before the FDA updated its cybersecurity guidance in 2023. When we submitted an application to expand our indications, FDA sent a host of cybersecurity questions. CyberMed quickly prepared the documentation we needed to support clearance. When it comes to medical device cybersecurity, these guys are legitimate experts.”
Jim O'Connor
CFO, Axena Health
Cleared a few weeks after an Additional Information request on SaMD deficiencies.
“During our FDA submission, we received an Additional Information request with several SaMD related deficiencies and a very tight timeline. CyberMed quickly understood our needs and reorganized all the relevant cybersecurity and software documentation, demonstrating a clear understanding of FDA expectations. Their efficiency, expertise, and practical guidance made a real impact. With their help, we got FDA clearance just a few weeks later!”
Angela Lema
Regulatory Affairs Specialist, TechFit Digital Surgery
Replaced a subpar penetration test with one that found the critical gaps.
“Our clinical intelligence platform depends on the confidentiality, integrity, and availability of its data and the security of its systems. We’d previously used another vendor for penetration testing, but their work was subpar. CyberMed delivered a far more rigorous assessment, identifying critical gaps and supporting our remediation. Their contribution gave us confidence that our FDA-regulated platform meets the highest standards.”
Tim Hanson
VP of QA/RA, Etiometry Inc.
From gap analysis to a cyber package that cleared FDA review.
“The CyberMed team is sharp, knowledgeable, and great to work with. They quickly reviewed our documentation, performed a cybersecurity gap analysis, and created a clear plan to secure our system. Then they created the documents and test report that led to FDA clearance. I highly recommend them to any medical device company.”
Pierre-Alexander Fournier
CEO, Hexoskin
The preferred cybersecurity partner for FDA consultants.
“As a 30-year-old consulting firm specialized on FDA compliance, MEDIcept sets a high bar on whom we'll partner with. CyberMed is our go-to partner for cybersecurity services because they're the best in the industry. They're fast, precise, and deeply knowledgable on both the technical and regulatory challenges related to cybersecurity. Plus they're a pleasure to work with.”
Bob Silva
VP, Engineering, MEDIcept Inc.
Embedded, mobile, and cloud, secured by one partner for years.
“For sophisticated systems that include embedded software, mobile applications, and cloud, CyberMed's expertise in cybersecurity is truly unparalleled in the industry. They've been a trusted partner for years and I couldn't recommend them more highly. Take it from someone who's been in IT and security for more than three decades.”
Mike Fong
CEO, Privoro
The industry publisher's pick for medical device cybersecurity.
“As the founder and publisher of MedTech Leading Voice, I have my finger on the pulse of the medical devices industry. With FDA's recent focus on cybersecurity, any medical device company hoping to commercialize a product with software needs a security expert on their side. CyberMed is unsurpassed in the industry. Their team is next level.”
Sean Smith
Founder, MedTech Leading Voices
Who's behind the work
There's no sales team. Your call is with our president, an MIT-trained engineering PhD and cybersecurity expert.
Meet the leadership team
Jose Bohorquez, PhD
President
Mohamad Foustok
Chief Security Officer
Andres Echeverry
Chief Operating Officer
The pieces reviewers look for, from one team.
CyberMed handles the cybersecurity documentation and independent testing your FDA submission needs. Our 30-day CyberSprint covers 12+ documents, with one team handling the work from security architecture through final test reports.
Security Architecture & Design
A secure device and smooth FDA review.
- Threat models and data flows tied to your actual device architecture
- Controls mapped to FDA guidance, AAMI SW96, and IEC 62304
- Design-control evidence your engineers and QA/RA team can defend in a review
Cybersecurity Documentation
An eSTAR cybersecurity section the reviewer accepts.
- Threat modeling, security risk assessment, and control rationale
- SBOM, vulnerability analysis, and level-of-support evidence
- Submission-ready summaries for labeling, anomalies, testing, and residual risk
Cybersecurity Testing
Third-party test evidence that holds up when FDA reads it.
- Penetration and fuzz testing across device, app, cloud, and the paths between them
- Reports with exploit evidence, severity rationale, and remediation status
- QA/RA-ready summaries for 510(k), De Novo, and PMA packages
You don't have to talk to anyone yet.
The first three steps are free and don't involve a conversation. All of them lead to the same call when you're ready for it.
- 1
Check your readiness
Fourteen questions, about three minutes, no account. You'll see where your evidence is thin before a reviewer does.
Start the check - 2
Read the book
Read our full medical device cybersecurity book one chapter at a time. No signup required.
Open chapter 1 - 3
See a sample gap report
A real gap report, so you can hold it up against your current cybersecurity package.
Get the sample - 4
Book a call
A security engineer tells you where you stand and what closing the gaps takes, whether or not we work together.
Pick a time - 5
30-day CyberSprint
Fixed price, fourteen deliverables, with the documentation and testing your medical device needs for FDA cybersecurity review.
See the offer
The complete documentation and testing package, in 30 days.
The CyberSprint includes fourteen deliverables across two phases for a fixed price. If FDA questions anything we prepared, no worries. We revise and respond at no extra cost. But seriously, it rarely comes to that.
See the full CyberSprint offerWeeks 1 to 3: architecture and documentation
Kickoff, architecture views, threat model, risk assessment, security controls, management plan, and test plan.
Weeks 3 to 4: testing and evidence
Penetration and fuzz testing, SBOM analysis, anomaly review, security metrics, and a final report with eSTAR checklist.
After submission
If FDA questions any cybersecurity material we prepared, we write your response within 24 to 48 hours at no charge.
Not ready to talk? Read along on Tuesdays.
You'll find short notes on medical device cybersecurity best practices, what's changing at FDA, and what it could mean for your next submission. We ask you to confirm your email, so nobody gets added by accident.
Join the CyberMed briefing
One email a week. Unsubscribe any time.
No fluff. Just actionable regulatory intel and remediation playbooks.
Find out where you stand before FDA tells you.
Thirty minutes with a security engineer. You leave with next steps even if you never hire us.
Prefer email? Send a note and we'll reply within one business day.