Is this aligned with current FDA cybersecurity expectations?

Yes. Mobile Application Penetration Testing is delivered against the FDA's 2026 premarket cybersecurity guidance, ANSI/AAMI SW96, ISO 14971, IEC 62304, and IEC 81001-5-1 - and structured to land cleanly in eSTAR.

How is the engagement priced and how long does it take?

Fixed-fee, scoped after a free 30-minute Discovery Session. Most premarket engagements (penetration testing, threat modeling, SBOM, deficiency response) complete in 4-8 weeks. We typically start within 1-2 weeks of contract signature.

What if the FDA still pushes back after we submit?

We back our work with a no-cost deficiency resolution commitment. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until that deficiency is closed. We cannot and do not guarantee clearance itself - that is the FDA's decision.

Application Security

Mobile Application Penetration Testing

OWASP MASVS-aligned mobile testing - local data storage, network communication, platform interaction, and binary protections.

The short answer

What does mobile app penetration testing cover for a medical device?

Mobile app penetration testing checks iOS and Android companion apps for weaknesses: data stored insecurely on the phone, weak network encryption or certificate checks, exposed secrets in the app code, and flaws in how the app pairs with and commands the device. Because the app often controls the device, findings are traced to the threat model and rated for patient-harm risk.

275+ FDA submissions supported, zero cybersecurity rejections.

Senior team
Fixed-fee
Reviewer-ready
Re-test included

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Trusted by leading MedTech manufacturers since 2022 · See client outcomes and awards

Reviewed by Christian Espinosa, MBA · Founder & CEO

Last reviewed

Attack surface

Mobile companion app surface

A medical-device companion app is rarely just a UI. It carries pairing material, holds patient data at rest, brokers BLE traffic, and talks to a cloud API that often has more privilege than the device itself.

01App binary (iOS / Android)
02Local storage (Keychain / Keystore, SQLite, files)
03BLE / Wi-Fi broker layer
04Pairing + bonding material handling
05Cloud API client + auth tokens
06Push / background-task channels
07Third-party SDKs (analytics, crash, ML)
08OS interop (clipboard, share, screen capture)

Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.

What's included

Reviewer-ready deliverables in one engagement

Every engagement ships with documented artifacts, traceable, complete, and aligned with current guidance.

Local data storage analysis
Network and API communication
Platform and IPC interaction
Binary hardening and reverse engineering

Why teams choose us

275+ FDA submissions supported, zero cybersecurity rejections
Fixed-fee pricing, scoped once, no scope-creep invoices
Aligned to the FDA's February 2026 premarket cybersecurity guidance
Senior MedTech cybersecurity engineer on every call, not an account manager
OWASP MASVS L2 + MASTG coverage across iOS and Android - static, dynamic, and network-layer
Local storage, keychain, biometrics, and cert-pinning bypass tested on real devices, not just an emulator

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Reference

Notable incidents

Public premarket cybersecurity history

Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about, and what this engagement is built to cover.

OWASP·Ongoing
OWASP MASVS / MSTG as reviewer baseline
OWASP MASVS is the de facto baseline reviewers compare mobile evidence against. A pen test that cannot point at MASVS coverage is now flagged.
Advisory

Also in premarket: SaMD CybersecurityMedical Device Penetration Testing ServicesWeb Application Penetration Testing

MedTech segments