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Published: May 27, 2026
Key Takeaways
- Real medical device pen testing runs $25K–$150K depending on hardware teardown, radio coverage, and cloud/mobile scope, not a flat rate.
- Cost is driven by attack surface, not device MSRP: a $2,000 wearable with BLE, a mobile app, and a cloud API can cost more to test than a $200,000 imaging system.
- FDA reviewers reject reports that read like automated scans; the labor to produce defensible manual evidence is the single largest line item.
- A mature threat model and [CycloneDX](/services/fda-compliant-sbom-services-for-medtech "FDA-compliant SBOM services") SBOM shipped up front reduce scoping labor by 15–25%, which we pass through in the quote.
- Cheap pen tests are the most expensive mistake: a rejected submission averages 90–180 days of lost market access plus a full re-test.
Part of our Medical device penetration testing series. For the full overview, start with FDA Penetration Testing Requirements.
A defensible medical device penetration test costs $25,000–$60,000 for a connected diagnostic or SaMD, $45,000–$90,000 for a Class II hardware device with BLE/Wi-Fi and a mobile companion, and $80,000–$150,000 for implantables, infusion pumps, or hospital-integrated platforms. Price scales with attack surface, hardware teardown depth, and the evidence FDA reviewers expect in the Section 524B cybersecurity submission, not with report page count.
The February 3, 2026 FDA final premarket cybersecurity guidance made pen testing a non-negotiable line item in every cyber device submission. The problem: "penetration testing" now covers everything from a $6,000 web-app scan to a $150,000 hardware-in-the-loop engagement, and reviewers can tell the difference in the first ten pages of the report.
Manufacturers who under-scope the test are the ones who show up in the Major deficiency queue two months later. Manufacturers who over-scope pay for coverage the threat model never asked for.
This guide breaks down what actually drives the price, what a defensible scope looks like for each device class, and where the cost curve bends when you already have a threat model and an SBOM in place.
Table of Contents
- Why Medical Device Pen Test Costs Vary
- Typical Price Ranges by Device Class
- The Six Cost Drivers in Every Quote
- Why "Cheap" Pen Tests Cause FDA Deficiencies
- How to Reduce Cost Without Losing Coverage
Why This Matters
The FDA's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (final, February 3, 2026) explicitly requires penetration testing evidence in every cyber device submission under Section 524B of the FD&C Act. Reviewers are trained to look for a defined scope, a testing methodology mapped to a recognized standard (NIST SP 800-115 or PTES), and findings tied back to the threat model.
Underscoped or automated-only reports are one of the most cited technical deficiencies in FDA's public cyber device correspondence, alongside SBOM gaps and threat model deficiencies aligned to AAMI TIR57. A rejected pen test triggers an Additional Information (AI) letter, a 180-day response window, and a re-test, typically at the sponsor's full expense.
The relevant standards reviewers cross-reference: ANSI/AAMI SW96:2023 for security risk management, AAMI TIR57 for threat modeling depth, IEC 81001-5-1 for secure software lifecycle, and ISO 14971 for hazard linkage. A pen test scoped without reference to these will look shallow to a reviewer who reads them daily.
Why Medical Device Pen Test Costs Vary
Medical device pen testing is a labor-intensive engagement, not a tool run. The price reflects the number of senior engineer-days required to exercise the device's full attack surface with the same methodology FDA reviewers expect to see.
Three variables move the number the most: connectivity breadth (how many interfaces, BLE, Wi-Fi, cellular, USB, mobile app, cloud API, a reviewer will expect covered), hardware depth (whether the scope includes UART/JTAG probing, chip-off analysis, or firmware extraction), and evidence density (whether findings must trace back to the threat model with reproducible steps and residual-risk statements).
Devices with only a cloud-hosted web UI test in a fraction of the time of a Class II hardware device with a BLE radio, a mobile companion app, and a cloud backend.
Typical Price Ranges by Device Class
Ranges below assume a defensible manual test with a written report, evidence pack, and re-test window suitable for a 510(k), De Novo, or PMA submission.
| Device profile | Typical range | Duration |
|---|---|---|
| SaMD / web-only diagnostic (cloud + optional API) | $25K–$45K | 3–4 weeks |
| Connected wearable or sensor (BLE + mobile app + cloud) | $45K–$75K | 4–6 weeks |
| Class II hardware device (Wi-Fi/BLE + mobile + cloud + firmware) | $60K–$90K | 5–7 weeks |
| Implantable or life-supporting device (RF + firmware + hardware teardown) | $80K–$150K | 7–10 weeks |
| Hospital-integrated platform (multi-device + HL7/DICOM + enterprise cloud) | $90K–$150K+ | 8–12 weeks |
Retests after remediation typically run 20–35% of the original engagement fee, depending on how much of the attack surface changed.
The Six Cost Drivers in Every Quote
Every scoping call comes down to the same six variables. Understanding them lets you compare quotes on the same axis instead of on headline price.
- Attack surface breadth. Every interface, BLE, Wi-Fi, cellular, USB, NFC, mobile app, web console, cloud API, HL7/DICOM, is a scoped testing lane. Adding a lane adds days, not hours.
- Hardware teardown depth. Non-invasive testing (attack the device as shipped) is the baseline. Invasive testing (JTAG/UART discovery, chip-off flash extraction, glitching) adds $10K–$30K but is often what reviewers expect for implantables and infusion devices.
- Firmware access model. Providing firmware images up front cuts reverse-engineering time significantly. Black-box firmware extraction adds a week of lab work.
- Radio coverage. BLE pairing/bonding attacks, Wi-Fi WPA2/3 flaws, and proprietary sub-GHz protocols each require different lab equipment and specialist time.
- Cloud and mobile scope. Companion apps and cloud backends are separate testing tracks. Skipping them creates the exact "incomplete attack surface" deficiency the FDA has been citing since 2024.
- Evidence density. A defensible report includes threat-model traceability, reproducible steps, remediation guidance, and residual-risk statements. That documentation labor is roughly 20–30% of total engagement hours.
Need a scoped quote instead of a range?
Blue Goat Cyber is a medical-device-only cybersecurity firm. Send us your device profile, connectivity diagram, and target submission pathway and we return a fixed-fee scope within 48 hours, no discovery-call gate. → Medical Device Penetration Testing
Why "Cheap" Pen Tests Cause FDA Deficiencies
See also: Fuzz Harness Generation for Medical, When to Start Medical Device Cybersecurity, and How SPDF Maps to IEC 81001-5-1 Activities.
The most common deficiency pattern we see in second-opinion engagements: a $8,000–$15,000 "pen test" that is really a Nessus or Burp Suite scan re-formatted into a PDF. Reviewers spot these in the first two pages.
The tells are consistent, no threat-model reference, no manual protocol analysis, no hardware or radio findings, no residual-risk statements, and a methodology section that cites "industry best practices" instead of NIST SP 800-115 or PTES. FDA does not reject the device on the pen test alone, but the AI letter arrives with "insufficient penetration testing to demonstrate adequate cybersecurity controls", and the clock stops.
The remediation is usually a full re-test at market rate, plus 90–180 days added to the review timeline. The net cost of a cheap pen test, once you account for the re-test and the delayed launch, routinely exceeds $200,000.
How to Reduce Cost Without Losing Coverage
There are legitimate levers that reduce cost without triggering deficiencies.
- Ship a threat model first. A STRIDE- or AAMI TIR57-aligned threat model with a documented attack surface cuts scoping labor by 15–25% and lets the testing team focus manual effort where it matters.
- Provide a CycloneDX SBOM. SBOMs with pURL identifiers eliminate the reverse-engineering cost of enumerating third-party components and known-CVE exposure.
- Freeze the firmware version. Testing a moving target adds re-scoping charges every sprint. Nominate a submission-candidate build for the engagement.
- Bundle premarket testing with the SBOM/VEX and threat-model workstreams. Sharing the same senior engineers across artifacts is where the real cost savings live, typically 10–20% versus buying each service standalone.
- Reuse test infrastructure across a device family. Sibling SKUs on the same platform can share lab setup and radio characterization work.
How Blue Goat Cyber Approaches This
Every pen test we ship is led by a senior medical-device security engineer who has personally worked on FDA cybersecurity submissions across 510(k), De Novo, PMA, and EU MDR pathways. Scope is fixed-fee, mapped to NIST SP 800-115 and PTES, and traced back to your threat model line by line.
We baseline your connectivity profile, interfaces, and intended use before quoting. Deliverables include a submission-ready report, an evidence pack, threat-model traceability, and a re-test window. Our Medical Device Penetration Testing engagement is the most common entry point; sponsors already in a deficiency loop typically start with FDA Cybersecurity Deficiency Response. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost.
Frequently Asked Questions
How much does medical device penetration testing cost?
Defensible manual pen testing runs $25K–$45K for SaMD, $45K–$90K for connected hardware devices with BLE/Wi-Fi and a mobile companion, and $80K–$150K for implantables or hospital-integrated platforms. Price scales with attack surface breadth, hardware teardown depth, and evidence density, not with device MSRP.
Is penetration testing required for every FDA medical device submission?
Yes for every cyber device under Section 524B of the FD&C Act. The February 3, 2026 final premarket cybersecurity guidance requires pen testing evidence in the submission, mapped to a recognized methodology and traced back to the threat model. Non-cyber devices (no software, no connectivity) are exempt.
Why are some pen test quotes 10x cheaper than others?
Because they are not the same product. Sub-$15K "pen tests" are typically automated vulnerability scans repackaged as reports. They do not include manual protocol analysis, hardware teardown, or threat-model traceability, and they are the leading cause of pen test deficiency findings in FDA AI letters.
How long does a defensible medical device pen test take?
Three to twelve weeks depending on scope. SaMD engagements run 3–4 weeks; Class II hardware devices with BLE and mobile 5–7 weeks; implantables and hospital platforms 7–12 weeks. Lab setup, firmware reverse engineering, and radio characterization dominate the schedule, not the exploitation itself.
Can I use a general IT penetration testing firm for my medical device?
Only if they can produce evidence mapped to AAMI TIR57, ANSI/AAMI SW96:2023, and the FDA's 2026 premarket guidance, and if they own the lab equipment for BLE, sub-GHz, and hardware-level testing. Most general IT firms cannot, which is why their reports draw AI letters even when the testing itself is technically competent.
Does the pen test cost include a re-test after remediation?
At Blue Goat Cyber, yes, a re-test window is included in every engagement. Industry-wide, re-tests are typically quoted separately at 20–35% of the original fee. Always confirm in writing before signing.
CTA
If you need a fixed-fee scope for your device, with an FDA-defensible methodology and a re-test window included, send us your device profile and target submission date. We return a written scope within 48 hours. Request a scoping call.
About the author
Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance, with 250+ device submissions across 510(k), De Novo, PMA, and EU MDR pathways. Read more about Christian.
