How Much Does Medical Device Penetration Testing Cost?

Medical device penetration testing can cost between $12,000 and $75,000, depending on system complexity and whom you choose as a test partner. The price is driven by five things: how many interfaces the device exposes, how complex the architecture is, how deep the testing goes (black vs. white box), how much FDA-grade reporting and traceability you need, and whether re-testing of fixes is included. Here's how each driver works and where you can actually save money.

What does the range look like by device type?

The published range is $12,000 to $75,000, with complex systems above it. Where a device lands inside that range follows its interfaces and the depth the submission needs. The tiers below are how CyberMed scopes; they describe position within the range, not a fixed quote, because every engagement is scoped from the architecture diagram and interface list.

Device profile	Typical interfaces in scope	Depth the submission usually needs	Position in the range
Standalone device with one service port	USB or serial, debug header, firmware image	Firmware review, physical interface testing, known-vulnerability scan of the SBOM	Low end
Wireless device with a companion app	BLE or Wi-Fi, mobile app, firmware, provisioning flow	Radio capture and protocol testing, app testing, pairing and update path	Middle
Cloud-connected device or SaMD with a backend	Device, app, cloud APIs, web portal, update server, identity provider	API and cloud testing, multi-tenant checks, update chain end to end, full FDA reporting with traceability	High end
Multi-device system or platform	Several device types, gateways, hospital network integration, fleet update	All of the above across each device type, plus multi-patient harm scenarios	Above the range

Two modifiers move a device up a tier: white box depth with source and schematics, and a compressed timeline. One moves it down: a finished threat model and architecture views, because scoping takes days instead of weeks and the test targets the trust boundaries the model already names.

Why is there no single price?

Because "medical device" spans a Bluetooth thermometer and a networked surgical robot. Testing effort scales with attack surface, and attack surface varies by orders of magnitude between devices. Any vendor who quotes you a fixed price before a scoping call is pricing a template, which is a red flag we cover in our guide to choosing a pen test vendor.

What we can do is show you the levers.

What drives the cost?

Interface count

The biggest single driver. Each interface is its own testing effort with its own tooling:

• Wireless: BLE, Wi-Fi, proprietary RF, NFC. Radio testing needs capture hardware and protocol work.
• Physical: USB, serial, JTAG/SWD debug ports, SD cards.
• Network services on the device itself.
• Companion mobile apps, desktop software, and cloud APIs.

A device with one BLE link and a mobile app is a fraction of the effort of a system with six of these. When you count your interfaces, count like an attacker: the maintenance port counts even if only technicians use it.

Architecture complexity

An RTOS on a single microcontroller tests faster than embedded Linux with a dozen services, which tests faster than a distributed system with edge devices and a cloud fleet. More components, more trust boundaries, more hours. If you've already documented the architecture and trust boundaries in a threat model, scoping gets cheaper and faster. Our post on STRIDE for medical devices shows what that looks like.

Testing depth

Black box testing (no internal knowledge) is cheaper per engagement but finds less per hour. White box testing with firmware images, source access, and schematics costs more up front and finds the issues that matter. For FDA purposes, deeper is usually the better spend: the goal is discovering vulnerabilities before reviewers or attackers do, not simulating a blind adversary. The types of penetration tests post goes deeper on the tradeoff.

Reporting depth

A findings list costs less to produce than an FDA-ready report with methodology, tester qualifications, CVSS scoring adjusted for patient harm, anomaly documentation, and traceability into your security risk assessment. The regulatory-grade report adds real hours. It's also the part that saves your submission, and it's what FDA reviewers actually check.

Re-testing

You'll fix the high-severity findings, and your submission needs evidence the fixes work. Verification re-testing adds cost either as an included line item or a later change order. Included is better; ask up front.

Three questions settle re-test pricing before you sign:

• How many verification passes are included, and on which severities? One pass on high and critical findings is the common floor.
• What is the window? A pass scheduled within a stated number of weeks of the final report keeps the tester's device knowledge fresh and the price down. An open-ended window is usually priced as a new engagement.
• What does the re-test report look like? FDA's guidance asks for the manufacturer's assessment of each finding. The re-test record should show the original finding, the fix, the verification method, and the result, so the submission carries a closed loop rather than two disconnected reports.

Timeline pressure

A deficiency response due in 30 days costs more than a test scheduled eight weeks out. Expedited engagements pull senior testers off other work. If you're pre-submission, schedule the test early and skip the rush premium entirely.

Where can you save money without hurting the result?

• Hand over engineering builds with debug access. Every hour a tester spends bypassing your own protections to reach the firmware is an hour not spent finding real vulnerabilities.
• Finish your threat model first. It focuses the test on the boundaries that matter and shortens scoping.
• Provide 3 to 5 test units so hardware work parallelizes and a bricked unit doesn't stall the engagement.
• Fix what you already know about. Paying testers to rediscover your known-issues list is expensive confirmation.
• Bundle. If the same firm handles your security testing stack (static analysis, fuzzing, pen test), shared device knowledge cuts ramp-up on each piece.

Where should you not save?

Skip the $5,000 automated scan dressed up as a pen test. FDA reviewers read enough reports to spot one, and the deficiency letter costs you a review cycle: months of delay, then a real test anyway. Same for certificate-only deliverables you can't put in an eSTAR submission.

Under-scoping is subtler but just as expensive. Cutting the cloud API or the debug port from scope to hit a budget number leaves a hole a reviewer can ask about. If budget forces scope choices, cut depth before you cut coverage, and document the rationale.

What must the report contain for the eSTAR?

The part of the price that is not optional is the report, because it is what FDA reads. Section V.C of FDA's premarket cybersecurity guidance (February 3, 2026) says penetration test reports should include:

• The independence and technical expertise of the testers, including who performed the testing and their level of independence from the developers.
• The scope of testing.
• The duration of testing.
• The testing methods employed, and for any tools, the name, version, and configuration used.
• The test results, findings, and observations.

The same section asks for the original third-party report when an outside firm tested, the manufacturer's assessment of every finding with rationale for any not fixed, and, for fixes deferred to a later release, the plan: which vulnerabilities, the timeline, whether fielded devices get the update, and how long it takes to reach them. It also lists what testing FDA expects to see alongside penetration testing: security requirements verification, threat mitigation testing against the architecture views, fuzz testing, attack surface analysis, vulnerability chaining, known-vulnerability scanning, software composition analysis of binaries, and static and dynamic analysis including hardcoded and default credential checks.

Two more items from the guidance affect scope and cost. Vulnerabilities found in testing are assessed under the security risk process, and the guidance notes that if a penetration tester could exploit a vulnerability, a threat actor's ability to exploit it is likely to increase over the device lifecycle. And after release, the guidance recommends periodic security testing at intervals commensurate with risk, giving annually as the example, which is why the postmarket plan required by Section 524B(b)(1) usually carries a re-test line.

The penetration test report post goes through a report section by section. The pen test prep checklist lists what to hand the tester on day one.

What does a quote look like in practice?

For a scoping conversation, expect a vendor to ask for your architecture diagram, interface list, threat model if you have one, and target submission date. From that, a real quote follows in days. If you want a number for your specific device, book a call and bring the architecture diagram. We'll scope it with you and tell you honestly which parts need depth and which don't. Details on our approach are on the penetration testing page.

Sources

1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, FDA, February 3, 2026. Section V.C, Cybersecurity Testing, lists the report elements and testing types above.
2. 21 U.S.C. 360n-2, Ensuring cybersecurity of devices, Section 524B of the FD&C Act.
3. Postmarket Management of Cybersecurity in Medical Devices, FDA, December 28, 2016.

Price figures on this page are CyberMed's published range from its own scoping experience. They are not quotes. Every engagement is scoped from the device's architecture and interface list.