How Much Does Medical Device Penetration Testing Cost?

Medical device penetration testing typically costs $15,000 to $75,000, with complex connected systems going higher. 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.

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.

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 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.