CyberMed
Medical Device Security Testing

Medical Device Penetration Testing

CyberMed helps medical device teams test connected products, document real findings, and turn security results into practical engineering and submission support.

Built for connected medical devices, not generic SaaS testing.

Device context

We look at the connected product ecosystem: device software, apps, APIs, cloud services, update paths, and supporting admin workflows.

Usable findings

The report should help engineering triage, fix, retest, and explain what changed after testing.

FDA-facing support

Findings should connect back to risk, controls, verification, remediation records, and the broader cybersecurity evidence package.

Who this is for

If your team is preparing for a submission, answering hospital security questions, or trying to validate the real-world security of a connected device, this page is for you.

Teams preparing a 510(k), De Novo, or PMA submission with connected-device cybersecurity questions
Companies answering hospital, partner, investor, procurement, or security-review questions
Engineering teams that need findings they can triage, fix, and retest
QA/RA leaders who need testing evidence tied back to cybersecurity risk and documentation

What we test

Scope starts with architecture and intended use. A typical engagement may include:

  • Device software or firmware
  • Mobile apps
  • Cloud services
  • APIs
  • Admin portals
  • Update paths
  • Local and remote interfaces
  • Supporting systems that affect device security

Testing tied to device risk

We focus on the parts of the system that can affect product security, safety-relevant workflows, evidence quality, and remediation decisions.

What you get

The output should help your team make decisions and act after testing.

Findings report with evidence and severity rationale
Engineering-focused remediation guidance
Executive summary for leadership or QA/RA review
Retest notes, if retesting is included in scope
How findings connect to cybersecurity risk and documentation work
Support explaining what was tested, what changed, and what remains

How testing supports FDA-facing work

Penetration testing is one input into the cybersecurity evidence package.

For connected medical devices, testing can support threat model validation, control verification, anomaly review, remediation records, and the cybersecurity testing narrative. It gives the team a clear record of what was tested, what was found, how risk was judged, and what happened next.

CyberMed works at the intersection of engineering, security, and FDA-facing documentation. The goal is a report your team can use in design reviews, remediation planning, and submission prep.

Why teams choose CyberMed

Generic security testing often stops at vulnerability findings. CyberMed starts with medical device context and writes findings your engineering, QA/RA, and leadership teams can use.

  • Connected-device architectures, including mobile, cloud, APIs, and update paths
  • How test findings should flow into engineering work
  • How evidence supports QA/RA and cybersecurity documentation
  • How to write findings so leadership, reviewers, and engineers can make decisions

Prep checklist

Get the penetration testing prep checklist

A better test starts before the first test case runs. This checklist helps your team prepare the scope, architecture context, access model, and deliverable expectations that make a penetration test more useful for engineering, risk management, and FDA-facing work.

  • Scope boundaries across device, firmware, mobile, cloud, APIs, update paths, portals, and interfaces
  • Architecture context, data flows, trust boundaries, protocols, authentication, and deployment model
  • User roles and access levels for patients, clinicians, technicians, admins, hospital IT, and integrations
  • Safety-relevant security risks that may affect therapy delivery, data integrity, alarms, availability, or clinical decisions
  • Test accounts, environment rules, test data, destructive-testing limits, and retest expectations

Practical checklist

Get the penetration testing prep checklist

Use this checklist to prepare for a test that supports engineering decisions, risk management, and FDA-facing documentation.

We'll send the checklist to your inbox after a quick confirmation.

FAQ

When should medical device penetration testing happen?

Usually after the architecture is stable enough to test meaningfully, but early enough that the team can still fix important findings without derailing the timeline.

Do you only test the device?

Not always. Depending on scope, testing may include mobile apps, cloud services, APIs, admin portals, and other connected systems that affect device security.

What does the client receive?

The exact package depends on scope, but the goal is a findings report with evidence, severity rationale, remediation guidance, and a clear path for follow-up decisions.

Does penetration testing replace the rest of the cybersecurity documentation work?

No. Testing supports the broader cybersecurity and submission story, but it does not replace threat modeling, risk management, documentation, or postmarket planning.

Can we start with penetration testing and expand later?

Yes. Some teams come in for testing first, then decide they want help with remediation support, cybersecurity documentation, or a broader readiness effort.

Talk through scope

Ready to scope a medical device penetration test?

If you want a second set of eyes on your device, supporting systems, and testing plan, we can help you define scope, run the engagement, and turn the output into something your team can actually use.

Start the consult request

A scoped test beats a rushed test.

Send us the product context you have. We'll help decide what should be in scope, what can wait, and what the final report needs to support.

Share a few details and we'll follow up about scoping a penetration testing consult.