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Automate software testing for medical devices

Code Intelligence's AI-driven fuzz testing platform helps developers keep critical bugs out of their code and ensure compliance with FDA’s and MDR’s testing requirements. Reach up to 100% code coverage with zero false positives.
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The role of fuzz testing in medical device cybersecurity

Fuzz testing is highly recommended by several American and European standards and guidance for medical devices cybersecurity. Non-compliance with these documents may lead to the denial of market approval.
 
The most important guidance documents advocating for fuzz testing:
 
  • Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions by the U.S. Food and Drug Administration (FDA)
  • AAMI TIR 57:2016 Principles For Medical Device Security - Risk Management
  • Guidance on cybersecurity for medical devices (MDCG 2019-16) by the European Commission and the Medical Device Coordination Group
  • IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security. Part 5-1: Security — Activities in the product life cycle.

Three reasons to use fuzzing for testing medical devices

Fuzz testing is widely used for testing embedded systems not only for compliance reasons.
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Detect critical issues
 
These include buffer overflows, memory corruption and other bugs relevant to memory-unsafe languages such as C/C++.
Fuzzing analyzes code dynamically. This ensures zero false positives - a finding is a finding.
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Uncover issues as early as you have executable code
 
Fuzz testing that analyzes source code can be integrated into the development process to test your code automatically as soon as you have an executable program - at the unit, integration, and system testing stages.
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Increase code coverage to up to 100%
 
Source code fuzzers leverage feedback about the software under test to reach the highest code coverage. Thus, you know how much of your code actually was executed during a test and what needs additional testing.
“Fuzz testing is state-of-the-art for testing robustness. Although you can write your own tests, you can never perform as many random and denial-of-service tests as you can with fuzzing. You must perform fuzz testing to prove to the FDA that your device is reliable and that the most common bugs are caught.”
Verana Wieser
Verena WieserMedical Device Consultant, Lorit Consultancy
“One of the biggest advantages of instrumented fuzz testing is that you can execute your code in a Software-in-the-Loop simulator. My favourite part of instrumented fuzzing is that finding the root cause is so easy, and for a manager, it means I can save budget.”
Michael von Wenckstern 2024
Michael Von WencksternProduct Cybersecurity Governance, Risk and Compliance Specialist, Continental AG
"Thanks to Code Intelligence fuzzing approaches, our security testing became significantly more effective. All our developers are now able to fix business critical bugs early in the development process, without false-positives."

 

Andreas Weichslgartner
Andreas WeichslgartnerSenior Technical Security Engineer, CARIAD
”Code Intelligence helps developers ship secure software by providing the necessary integrations to test their code at each pull request, without ever having to leave their favorite environment. It's like having an automated security expert always by your side.”
thomas-dohmke
Thomas DohmkeCEO, GitHub

See fuzz testing in action

Automotive, telecom, machinery, medical devices, and IoT manufacturers leverage Code Intelligence to test their products, effectively reducing the risk of delayed releases, costly fixes, malfunctions in critical systems, and cyber attacks.
 
Book a call with us to learn more on how you can:

  •  Automate software testing for medical devices.
  • Detect critical bugs & vulnerabilities early in the development.
  • Uncover only actual issues without false positives.
  • Enable developers to reproduce & fix issues in minutes, not weeks.
  • Ensure compliance with FDA's and MDR's testing requirements.

Frequently asked questions

What is fuzz testing again?

Fuzzing is a dynamic application security testing method used for finding functional bugs and security issues in software. During a fuzz test, a program gets executed with invalid, unexpected, or random inputs, with the aim to crash the application. Fuzzing is proven highly effective for testing embedded systems like medical devices. Learn more about fuzzing in this blog post.
Does fuzzing integrate into CI/CD pipeline?

Yes, the integration allows automatically test your software with every pull request. This ensures regressions and release blockers are identified long before reaching production.
We regularly do penetration testing. How does fuzzing contribute to pentests?

Do fuzz testing first to identify all possible issues automatically, view the percentage of code covered, and identify parts of the software requiring targeted pentest. Thus, you can optimize the efforts of penetration testers by focusing on areas untouched by fuzzing.

Useful resources

Vector

Fuzzing in FDA’s requirements for medical device security

Learn about the United States Food and Drug Administration’s cybersecurity requirements for medical devices and how fuzz testing plays a role in compliance.  

Vector

Best practices for embedded security testing

Navigate the complexities of embedded software security with our expert guide. Learn best practices, explore dynamic and static analysis tools, and discover how CI/CD-integrated fuzz testing enhances safety and security.

Vector

Securing medical devices: role of fuzz testing in cybersecurity

Discover how fuzz testing addresses the 59% rise in medical device vulnerabilities in 2023. Learn why the FDA and European Commission recommend this method to enhance patient safety and device security.