FDA-ready cybersecurity that helps MedTech leaders launch with confidence.
CyberMed is the partner medical device innovators trust to help secure their products, prepare airtight documentation, and validate their systems through thorough cybersecurity testing. And we do the heavy lifting so your team can stay focused on innovating.
35+ yrs
Cybersecurity experience
20+ yrs
FDA & MedTech experience
100%
Submissions success
See the Medical Device Cybersecurity Quick-Start in action
Watch a guided walkthrough of the 30-day plan we use to align teams, artifacts, and timelines with FDA cybersecurity expectations.
Trusted by MedTech leaders delivering complex, connected devices.
Executives responsible for commercialization, compliance, and product security rely on CyberMed to answer FDA scrutiny and keep launches on track.
“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 and meet FDA requirements. Their expertise and efficiency made a huge impact. I highly recommend them to any medical device company.”
Pierre-Alexander Fournier
CEO, Hexoskin
“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.
“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
“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
“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.
“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
Built for founders and QA/RA leaders who refuse to let cybersecurity derail their FDA submission.
FDA cybersecurity requirements are complex and constantly evolving. CyberMed delivers the security architecture, documentation, and testing that pass FDA review the first time, so you can launch with confidence.
- FDA clearance on the first submission with no back-and-forth over missing cybersecurity documentation.
- Reduced engineering workload by 95% so your team stays focused on innovation while we handle compliance.
- Accelerated time to market by 3 to 9 months through proactive cybersecurity that prevents costly rework and regulatory delays.
Secure Products
Secure medical devices that can withstand FDA scrutiny, investor due diligence, and evolving post-market threats.
FDA-Ready Documents
Security architecture views, threat models, SBOMs, and test artifacts that reviewers accept without pushback.
Cybersecurity Testing
Penetration and fuzz testing that uncovers vulnerabilities before FDA or hackers do, protecting patients (and your business).
Post-Market Monitoring
Continuous vulnerability management, SBOM analysis, and security surveillance to maintain security and compliance after clearance.
Everything you need to earn regulatory confidence.
We work with your engineering, quality, and regulatory teams to ship devices that are secure by design and supported by evidence.
Security Architecture & Design
Develop security architectures and data flows that balance usability, regulatory demands, and speed-to-market.
- System-level threat modeling with actionable mitigations
- Secure-by-design patterns tailored to your device
- Design controls mapped to SW96, 62304, and FDA guidance documents
FDA Cybersecurity Artifacts
We prepare the documents, evidence, and narratives reviewers expect in modern submissions.
- Security architecture views, threat modeling, risk assessment, and security controls
- SBOMs, vulnerability analysis, and level-of-support analysis
- Assessment of unresolved anomalies, cybersecurity metrics, security management plan, and labeling
- Interoperability risk assessment, cybersecurity test reports, security risk management report, and more
Secure SDLC Acceleration
Embed security and compliance in your software lifecycle without slowing agile development.
- SDLC gap analysis and remediation roadmap
- DevSecOps tooling and workflow playbooks
- Launch-day monitoring & post-market surveillance enablement
The CyberMed CyberSprint aligns teams in weeks, not months.
1. Illuminate the attack surface
End-to-end architecture mapping, threat modeling, and control scoring to identify blind spots before regulators do.
2. Orchestrate remediation
Prioritize mitigations, validation activities, and document updates in a joint backlog your teams can execute immediately.
3. Deliver the FDA narrative
Package the evidence, traceability, and reviewer briefings required to support your submission or audit.
Stay in lockstep with evolving FDA cybersecurity expectations.
Every Tuesday we distill regulatory shifts, remediation tactics, and submission lessons learned from MedTech launches in the field.
Join the CyberMed briefing
Confirmation required. No spam—just actionable guidance.
No fluff. Just actionable regulatory intel and remediation playbooks.
Ready to de-risk your FDA submission?
Let's build a cybersecurity program that accelerates approval and earns stakeholder trust.