Medical Device Penetration Testing

Penetration testing for medical devices isn't IT pen testing with a stethoscope. The attack surface, the safety implications, and the FDA's evidence expectations are all different. This hub collects our pen-testing services, methodology, common findings, and the standards reviewers expect to see in your report.

Services

• Medical Device Penetration Testing

  Hardware, firmware, mobile, and cloud - tested by operators with both red-team and medical-device experience. Reports built for FDA reviewers.

• White Box Penetration Testing

  Deep, full-knowledge assessment using source code, data flow diagrams, and administrative access - surfacing issues that black-box testing cannot reach.

• Gray Box Penetration Testing

  Combines black box techniques with limited credentials and architecture knowledge - ideal for application testing and insider-threat simulations.

• Black Box Penetration Testing

  Adversary simulation with zero prior knowledge - emulates an external attacker probing your perimeter, applications, and exposed services.

• Pen Testing Methodology

  A documented, repeatable testing methodology aligned with the FDA's 2026 premarket guidance, ANSI/AAMI SW96, ISO 14971, IEC 62443-4-1, and NIST 800-115 - designed to minimize risk to live systems and produce evidence that maps cleanly into your ISO 13485 quality records.

In-depth guides

• 12 Critical Findings from Medical Device Pen TestsFree Pen-Test Guide · Updated 2026 · FDA-Aligned 12 Critical Findings from Medical Device Penetration Tests A practical, ungated guide to the most common high- and critical-severity findings we surface in medical device pen tests, what each one looks like in the field, and exactly how to fix it befo
• 10 Reasons Cybersecurity Vendors Fail MedTechFree Buyer’s Guide · 10 Pages · Updated Apr 2026 10 Reasons Medical Device Cybersecurity Vendors Fail You A practical, ungated buyer’s guide for manufacturers comparing Blue Goat Cyber to platform vendors, hospital network defense firms, and generalist consultancies. What goes wrong, why it costs yo

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
• ANSI/AAMI SW96Medical Device Security Risk ManagementThe consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
• IEC 81001-5-1Health Software Security ActivitiesThe international standard the FDA points to for the Secure Product Development Framework (SPDF). Defines security activities at each lifecycle stage - planning, requirements, design, implementation, V&V, release, and post-market.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.

From the blog

• 25 Use Cases for White-Box Penetration TestingThis article explores white box penetration testing use cases and their importance in ensuring robust cybersecurity.
• A Comprehensive Guide to Software Testing for Medical DevicesLearn the ins and outs of software testing for medical devices in this comprehensive guide.
• Abuse and Misuse Cases: Testing Medical Devices with Malformed and Unexpected InputsExplore the critical importance of testing medical devices against malformed and unexpected inputs to prevent abuse or misuse.
• Risk-Based Testing for Medical Device SoftwareExplore the intricacies of risk-based testing for medical device software in this comprehensive guide.

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.