Medical Device Penetration Testing Cost: 2026 Guide

Part of our Medical device penetration testing series. For the full overview, start with FDA Penetration Testing Requirements.

Every manufacturer asks the cost question at some point, and almost every vendor answers it with "it depends, let's get on a call." That answer is not wrong, but it is not useful to an engineering lead trying to size a budget line six months before a 510(k) submission, or a founder trying to decide whether a Series B round needs to fund the work now or after the next design freeze.

This guide breaks down exactly what moves the price of a medical device penetration test: the interfaces in scope, the physical teardown work, the wireless and RF testing, the cloud and mobile companion surface, and the report depth reviewers actually expect to see. It closes with how a fixed-fee model changes the risk calculus and what a realistic 2026 price range looks like by device category.

Why Medical Device Pen Test Pricing Looks Nothing Like IT Pen Testing

A generic web or network penetration test is priced against a handful of well-understood variables: number of IP addresses, number of web applications, number of user roles. Medical device penetration testing is priced against a fundamentally different set of variables, because the target is rarely a single system. It is a stack of systems that a general IT firm has usually never tested together: embedded firmware running on a real-time operating system, a proprietary or standards-based wireless link, a companion mobile app, a cloud backend that ingests patient data, and often a clinician-facing web portal on top of all of it.

Each of those layers requires a different skill set and different tooling. A firm that only does web application testing can produce a report that looks thorough while never touching the firmware or the RF link, the two places where the most consequential vulnerabilities in connected medical devices tend to live. That mismatch is exactly why "cheap" quotes are cheap: they scope out the hard, expensive parts of the device and leave the manufacturer with a report that will not survive scrutiny from an FDA reviewer.

The FDA's February 3, 2026 premarket cybersecurity guidance makes the expectation explicit: cybersecurity testing has to be commensurate with the device's cyber risk, covering the full attack surface identified in the threat model, not just the layer that is easiest to test. ANSI/AAMI SW96:2023 reinforces the same point from the process side, requiring that security testing trace back to the risk management file and the threat model rather than existing as a standalone checklist exercise. Pricing that ignores this reality is pricing for a report that will not clear review, which makes it more expensive in the long run, not less.

The Core Cost Drivers

Five variables account for most of the difference between a $20,000 quote and a $90,000 quote, and any competent vendor should be able to walk you through all five before naming a number.

Number and type of interfaces. A device with a single wired USB service port is a fraction of the effort of a device with BLE, Wi-Fi, a proprietary 900 MHz link, a cellular modem, and a cloud API all active at once. Each interface is its own test discipline with its own tooling, and the cost scales with the count, not with the device's physical size or price point.

Hardware access and teardown depth. Testing that stops at the software boundary is materially cheaper than testing that includes chip-off firmware extraction, JTAG/SWD debug port analysis, side-channel review, and physical tamper testing. Implantables, infusion pumps, and other devices where physical possession by an attacker is a realistic threat scenario require the deeper (and pricier) teardown work.

Wireless protocol complexity. Standard Bluetooth Low Energy testing against a known GATT profile is a known quantity. Proprietary RF protocols with custom framing require reverse engineering the protocol itself before any vulnerability testing can start, which adds days of analyst time before the "real" testing even begins.

Cloud and mobile companion scope. Most connected devices today ship with a companion app and a cloud backend that need testing in their own right: API authentication and authorization, data-at-rest and in-transit encryption, session management, and the mobile app's local storage and binary hardening. This is effectively a second, parallel pen test bolted onto the device test.

Report and evidence depth for regulatory submission. A report destined for an FDA submission needs to trace every finding back to the threat model, map to ANSI/AAMI SW96:2023 test categories, and document CVSS scoring, exploitability, and residual risk in a form a reviewer can audit line by line. That level of documentation takes measurably more time than a findings list built for an internal security team.

Firmware and Hardware Teardown

Firmware and hardware testing is where medical device penetration testing diverges most sharply from IT testing, and it is usually the largest single line item in a quote. A thorough engagement includes extracting firmware from flash or EEPROM, analyzing the boot chain for secure boot and signature verification, reviewing update mechanisms for signing and rollback protection, and probing debug interfaces (JTAG, SWD, UART) that are often left active in production hardware.

Devices that store cryptographic keys or PHI locally add key management review to that scope: is the key material protected by a hardware security element, or is it sitting in flash where a $50 programmer and an afternoon can pull it out? Devices with physical tamper-evidence claims need dedicated tamper testing to validate those claims hold up against a motivated attacker, not just a curious one.

The cost implication is straightforward: a software-only device (an app that processes data from a cleared device but has no firmware of its own) can skip this category entirely, while an implantable neurostimulator or an infusion pump needs the full teardown, and that difference alone can account for a $20,000-$30,000 swing in the final quote.

Wireless and RF Testing

Wireless testing cost tracks protocol complexity more than protocol popularity. Bluetooth Low Energy is common, but a device using a custom GATT profile with proprietary characteristics still requires the tester to reverse the profile before testing pairing security, encryption, and replay resistance. Wi-Fi-connected devices need testing against the same authentication and encryption weaknesses that affect any Wi-Fi client, plus device-specific questions like whether the device validates the network it joins or blindly trusts any AP with the right SSID.

Proprietary sub-GHz RF links (common in infusion pumps, patient monitors, and glucose sensors) are the most expensive category, because there is no off-the-shelf tooling. The tester has to capture and reverse-engineer the over-the-air protocol with a software-defined radio before any real vulnerability analysis can begin, and that reverse-engineering phase alone can take a week or more of dedicated analyst time.

Zigbee, Z-Wave, and NFC show up less often but follow the same rule: the more proprietary and undocumented the protocol, the more billable time it takes before testing starts, and the higher the quote.

Cloud Backends and Mobile Companion Apps

Few connected devices ship without a cloud component today, and most have a mobile app that pairs with the device and often authenticates the patient or clinician. Both need to be in scope, and both add cost proportional to their own complexity, independent of the device hardware.

Cloud backend testing covers API authentication and authorization (including the increasingly common failure mode of a mobile app or device holding a static API key that grants far broader access than intended), data encryption in transit and at rest, multi-tenancy isolation if the platform serves multiple hospital customers, and logging and monitoring sufficient to detect an intrusion after the fact.

Mobile companion app testing covers local data storage (is PHI or device pairing data sitting unencrypted in app storage), certificate pinning and transport security, reverse engineering resistance, and the authentication flow between the app, the device, and the cloud backend. A device with a thin, read-only companion app is a modest addition to scope. A device where the app is the primary clinician interface, pushing therapy adjustments to the device itself, is effectively a second full application pen test.

Report Depth for an FDA Submission

The deliverable itself is a cost driver that manufacturers routinely underestimate. A pen test report built for internal use can be a findings list with severity ratings and remediation notes. A report built to support an FDA submission has to do considerably more work.

Under the FDA's February 3, 2026 premarket cybersecurity guidance, submitted testing evidence needs to demonstrate that testing was scoped against the device's own threat model and SBOM, not a generic checklist, and that findings were resolved or formally risk-accepted before submission. ANSI/AAMI SW96:2023 adds structure on top of that, defining test categories (including fuzz testing, vulnerability scanning, and structured penetration testing) that a mature security risk management process is expected to address, with traceability back to the risk management file required by ISO 14971.

See also: Fuzz Harness Generation for Medical, When to Start Medical Device Cybersecurity, and How SPDF Maps to IEC 81001-5-1 Activities.

Producing a report that satisfies both means every finding needs a CVSS score, an exploitability narrative specific to the clinical use environment, a mapping to the relevant SW96 test category, and a remediation or risk-acceptance record that a reviewer can trace independently. That is a materially different (and more time-consuming) deliverable than a standard pen test report, and it is one of the reasons a "penetration test" quoted by a generalist security firm for $8,000 and a medical-device-specific engagement quoted at $35,000 can be testing the same device.

Pricing Factors at a Glance

Typical Price Ranges by Device Category

These are representative fixed-fee ranges for the penetration test itself, not the full cybersecurity submission package. Actual quotes vary with the specific interfaces and teardown scope described above.

A full premarket cybersecurity package, pen testing plus threat modeling, SBOM analysis, security architecture review, and submission documentation, typically runs $40,000-$120,000 depending on where the device falls in the table above.

Fixed-Fee vs Hourly: Why the Pricing Model Matters

The pricing model changes the risk profile of the engagement as much as the scope does. Hourly billing looks predictable at the quote stage, but medical device pen tests almost always surface findings that need remediation and a re-test, and hourly firms bill every one of those re-test cycles separately. A device that needs three remediation-retest passes before it clears can see its final invoice run well past the original estimate.

Fixed-fee engagements with unlimited retesting included remove that risk from the buyer's side. The firm commits to a price for the defined scope and absorbs the cost of retesting until the device reaches an acceptable risk posture, which is the norm at Blue Goat Cyber and the model we recommend evaluating any vendor against. It also aligns incentives correctly: a fixed-fee firm has no financial reason to find (or manufacture) extra billable hours, which matters when the FDA is going to scrutinize the independence and rigor of the testing team's work.

Turnaround time is part of the same conversation. A well-scoped engagement for a single- or dual-interface device typically completes in two to four weeks from kickoff to final report, assuming test hardware and documentation (architecture diagrams, SBOM, existing threat model) are available at the start. Devices requiring extensive RF reverse engineering or full hardware teardown run toward the longer end of that window, or beyond it, because the reverse-engineering phase cannot be compressed by adding more testers.

How to Control Cost Without Cutting Corners

The manufacturers who get the best price-to-value outcome share a few habits, none of which involve reducing the actual test scope.

Scope before design lock. A threat model built during architecture, not after, tells the testing team exactly which interfaces matter and lets them price accurately on the first pass instead of discovering scope mid-engagement.

Bring an existing SBOM and threat model to the quote conversation. Testing teams that have to build a threat model from scratch before they can even scope the engagement are pricing in that discovery work. A current SBOM and architecture diagram routinely shave real money off the quote.

Test once, correctly, instead of a cheap first pass and an expensive second pass. A generalist IT pen test that misses the firmware and RF layers will surface as an FDA deficiency later, and the second, corrective engagement plus the resubmission delay costs far more than doing the medical-device-specific test correctly the first time.

Separate the premarket test from ongoing postmarket obligations. Under Section 524B, postmarket vulnerability monitoring and periodic testing are recurring obligations, not part of the initial premarket pen test. Budgeting them as one line item leads to either an inflated premarket quote or an underfunded postmarket program.

How Blue Goat Cyber Approaches Medical Device Penetration Testing Cost

We price every engagement fixed-fee with unlimited retesting, because a device does not reach acceptable risk on a schedule that fits a single test pass, and the buyer should not carry that uncertainty on an hourly meter.

• Scoping against the real attack surface. We map every interface, firmware, wireless, mobile, and cloud, before naming a price, so the quote reflects the device you are actually shipping rather than a generic device profile.
• Testing teams that cover hardware and software. Firmware reverse engineering, RF protocol analysis, and application testing are handled by engineers who do that work daily, not generalists extending an IT pen test into hardware.
• Reports built for FDA review. Every finding is traced to the threat model and mapped to ANSI/AAMI SW96:2023 test categories, so the report is ready to support a submission under the FDA's February 3, 2026 premarket cybersecurity guidance without a second drafting pass.
• Two-to-four-week turnaround on well-scoped engagements. We give you a calendar date at kickoff, not a "we'll let you know" once testing starts.
• A single fixed number, no re-test surcharges. If a finding needs a fix and a re-test, that re-test is included, not a change order.

If you want a scoped, fixed-fee number for your device, our Medical Device Penetration Testing service page walks through methodology and deliverables, and FDA Premarket Cybersecurity Services covers the full submission package if you need threat modeling and documentation alongside the test itself.

FAQ

How much does a medical device pentest typically cost?

Costs scale with the number of interfaces, hardware teardown depth, and report requirements. A representative fixed-fee test for a connected diagnostic device runs $25,000-$60,000, and a full premarket cybersecurity package, including threat modeling and submission documentation, typically runs $40,000-$120,000.

What factors increase the price of medical device cybersecurity testing?

The largest factors are the number and type of interfaces in scope (firmware, wireless, mobile, cloud), whether hardware teardown and physical tamper testing are required, the complexity of any proprietary wireless protocol, and the depth of report needed to satisfy the FDA's February 3, 2026 premarket cybersecurity guidance and ANSI/AAMI SW96:2023. A missing or outdated threat model also adds cost, because the testing team has to build one before scoping can even start.

Does the FDA require penetration testing for all Class II devices?

Penetration testing is expected for any cyber device under Section 524B where the threat model identifies exploitable interfaces, which covers the great majority of connected Class II devices. The February 3, 2026 guidance ties the required depth of testing to the device's cyber risk rather than its device class alone, so the safest approach is to scope testing against your specific threat model rather than assuming class determines whether testing is needed.

How long does a medical device penetration test take to complete?

A well-scoped engagement for a single- or dual-interface device typically takes two to four weeks from kickoff to final report, assuming test hardware and existing documentation are available at the start. Devices requiring extensive proprietary RF reverse engineering or full hardware teardown can run longer, since that analysis cannot be shortened simply by adding staff.

Can I use a general IT pentest firm for my medical device?

A general IT pen test firm can competently test a device's web portal or cloud API, but most lack the firmware reverse engineering and RF protocol analysis capability that medical devices require, and a report missing those layers will not satisfy an FDA reviewer looking for testing commensurate with the device's full threat model. If your device has no firmware or wireless attack surface at all, a general firm may be sufficient; almost no connected medical device meets that bar.

Get a fixed-fee number for your device

Use the Scope Estimator for a self-serve pricing range, or book a strategy call and we will scope your device's interfaces, teardown needs, and submission timeline against a written, fixed-fee commitment.

Sources

• U.S. Food and Drug Administration, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, final guidance issued February 3, 2026.
• ANSI/AAMI SW96:2023, Standard for Medical Device Security Risk Management.
• FD&C Act Section 524B, Ensuring Cybersecurity of Devices.
• ISO 14971, Medical devices - Application of risk management to medical devices.