Medical Device Penetration Testing Cost: Pricing Guide

Understand the factors influencing medical device penetration testing cost, from FDA requirements to device complexity. Get a transparent pricing breakdown.

This guide is written for medical device manufacturers navigating medical device penetration testing cost. It is built from real submissions, FDA correspondence, and the standards reviewers actually cite. Use it as a working reference: read straight through, jump to the section that matches your current gap, or hand it to your engineering and regulatory leads as a checklist.

Why Medical Device Penetration Testing Costs Vary

Why Medical Device Penetration Testing Costs Vary is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Complexity of the Device Ecosystem

Complexity of the Device Ecosystem — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Scope of Hardware and Physical Interface Testing

Scope of Hardware and Physical Interface Testing — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Regulatory Requirements (FDA vs. EU MDR)

Regulatory Requirements (FDA vs. EU MDR) — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Average Price Ranges for Medtech Pentesting

Average Price Ranges for Medtech Pentesting is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Small-Scale Diagnostic Tools and Software-Only Devices

Small-Scale Diagnostic Tools and Software-Only Devices — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Integrated Systems and Implantables

Integrated Systems and Implantables — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Enterprise Hospital Ecosystems and Cloud Backends

Enterprise Hospital Ecosystems and Cloud Backends — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Critical Factors Affecting Your Pentest Quote

Critical Factors Affecting Your Pentest Quote is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Hardware Disassembly and Reverse Engineering

Hardware Disassembly and Reverse Engineering — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Wireless Protocol Testing (BLE, Wi-Fi, Zigbee)

Wireless Protocol Testing (BLE, Wi-Fi, Zigbee) — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Threat Model Maturity and Existing SBOMs

Threat Model Maturity and Existing SBOMs — make sure your design history file documents the rationale, the standard you mapped to, and the objective evidence that closes the loop. Reviewers expect to trace the requirement, the test, and the residual risk in a single thread.

Why 'Cheap' Pentests Result in FDA Deficiencies

Why 'Cheap' Pentests Result in FDA Deficiencies is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

How to Reduce Pentesting Costs Without Sacrificing Safety

How to Reduce Pentesting Costs Without Sacrificing Safety is one of the areas FDA reviewers probe hardest in modern submissions. The points below summarize what we ship in client packages and what we have seen FDA accept and reject across 250+ device submissions.

Frequently asked questions

### How much does a medical device pentest typically cost?

Short answer: Costs scale with device complexity, attack surface, and the depth of testing you need; a representative pen test for a connected diagnostic device runs $25–$60K, and a full premarket cybersecurity package $40–$120K. For the full context, work through the relevant section above and the linked services below — every answer here is grounded in current FDA guidance and the standards your reviewer is using.

What factors increase the price of medical device cybersecurity testing?

Short answer: It depends on the device classification, intended use, and connectivity profile — but the controlling references are FDA's February 2026 premarket guidance, AAMI SW96, and IEC 81001-5-1. The sections above walk through how each applies. For the full context, work through the relevant section above and the linked services below — every answer here is grounded in current FDA guidance and the standards your reviewer is using.

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

Short answer: Yes — under Section 524B and the February 2026 final guidance, every cyber device requires the artifact in question. Skipping it is the fastest way to an RTA hold. For the full context, work through the relevant section above and the linked services below — every answer here is grounded in current FDA guidance and the standards your reviewer is using.

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

Short answer: FDA gives sponsors 180 days to respond to a Major deficiency / AI letter (15 days for an RTA hold). Plan for two iteration cycles; teams that ship a clean response in one round are the ones with a working SPDF. For the full context, work through the relevant section above and the linked services below — every answer here is grounded in current FDA guidance and the standards your reviewer is using.

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

Short answer: It depends on the device classification, intended use, and connectivity profile — but the controlling references are FDA's February 2026 premarket guidance, AAMI SW96, and IEC 81001-5-1. The sections above walk through how each applies. For the full context, work through the relevant section above and the linked services below — every answer here is grounded in current FDA guidance and the standards your reviewer is using.

Where this fits in the cluster

This page sits downstream of our pillar resources on medical device penetration testing cost. If you arrived here from a different starting point, these are the most useful adjacent pages:

• Medical Device Penetration Testing
• 12 Critical Findings from Medical Device Penetration Tests
• FDA Premarket Cybersecurity Services

Related from Blue Goat Cyber

• Medical Device Threat Modeling
• The MedTech Cybersecurity Standards Decoder
• FDA Cybersecurity Deficiency Response
• FDA-Compliant SBOM Services
• 12 Critical Findings from Medical Device Penetration Tests

Sources & primary references

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions — U.S. Food and Drug Administration (FDA)
• Technical Guide to Information Security Testing and Assessment (SP 800-115) — NIST
• ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management — AAMI
• Postmarket Management of Cybersecurity in Medical Devices — U.S. Food and Drug Administration (FDA)

Talk to a regulatory cybersecurity team

If you are working through medical device penetration testing cost and want a second pair of eyes on your submission package, we ship cybersecurity deliverables for medical device manufacturers across 510(k), De Novo, PMA, and EU MDR pathways. Book a discovery session and we will walk your evidence with you.