In medical device software, there’s no such thing as a “small” bug. One flaw in the testing process can ripple into real-world consequences: compliance issues, product recalls, even risks to patient safety.
That’s why relying only on manual testing doesn’t cut it anymore. It’s slow, it misses edge cases, and it produces the kind of gaps auditors love to point out. What teams need are automated testing tools built for the reality of medical devices: strict regulations, endless compliance documentation, and the pressure to move fast without breaking things.
The right test automation strategy helps you increase test coverage, reduce human error, and generate reliable test results, all while proving your medical device software meets IEC 62304 and other standards. More coverage, less firefighting, and a smoother software development cycle.
In this article, we’ll walk through five of the best test automation tools for medical devices and show how they help you balance speed, compliance, and product quality.
What are the most important factors when deciding on your medical device testing software?
When evaluating test automation tools for medical devices, you’re not just comparing features, you’re validating whether the tool can operate under the constraints of regulated industries while delivering reliable test results. These are the core technical criteria to assess:
1. Compliance and traceability
A tool must natively support regulatory frameworks such as IEC 62304, ISO 14971, and FDA 21 CFR Part 11. This includes:
- Full traceability from requirements → design inputs → test cases → defects.
- Automatic generation of compliance documentation with electronic signatures and audit trails.
- Clear separation of verification vs. validation activities to satisfy notified bodies and auditors.
Without this, you’ll struggle to pass audits or prove that your software validation aligns with safety standards.
2. Test coverage across environments
Modern medical device software isn’t limited to embedded systems. It spans operating systems (Windows, Linux, RTOS), mobile apps (iOS, Android), web applications, and integrations with other systems such as hospital information systems (HIS) or lab equipment. The chosen tool must support:
- Multi-platform execution with minimal script duplication.
- Higher test coverage for both functional and non-functional requirements (latency, throughput, data security).
- Seamless integration with simulators and hardware-in-the-loop setups to replicate real-world conditions.
3. Automation reliability and CI/CD integration
Flaky automation undermines quality assurance. Tools must provide:
- Deterministic object recognition that withstands UI updates and layout changes.
- Robust handling of edge cases and timing issues through intelligent waits and retries.
- Native integration with CI/CD (Jenkins, GitLab, Azure DevOps) to enable continuous testing at every commit.
- Support for parallel execution to reduce execution time for large regression suites.
4. Risk management and safety-critical focus
In regulated environments, testing equals risk management. Tools should:
- Link hazards and risk controls directly to test cases.
- Support reliability testing and regression testing with configurable severity and priority levels.
- Provide objective evidence that patient safety requirements are verified in every release.
5. Configurability, extensibility, and scalability
The tool must fit into your development process, not the other way around. Key capabilities include:
- Highly configurable test execution workflows that adapt to different device types.
- Open APIs for integration with ALM tools (e.g., Polarion, Jama) and test management systems.
- Support for source code control, branching, and versioning to align with software engineering practices.
- Ability to scale from a handful of smoke tests to thousands of automated scenarios without collapsing under maintenance overhead.
6. Efficiency and lifecycle costs
Finally, evaluate total cost of ownership (TCO):
- How much manual testing is eliminated without losing coverage?
- Can the tool actually reduce time-consuming maintenance, or will brittle tests drive costs up?
- Does it provide reusable, modular test automation assets that can be applied across devices, versions, and systems?
Best test automation tools for medical devices
The market is full of automated testing tools, but not all of them are built to handle the unique demands of medical device software. Between strict regulatory requirements, the need for detailed compliance documentation, and the pressure to guarantee patient safety, only a handful of tools truly stand out.
Below are five of the most widely used test automation tools for medical devices. Each brings different strengths to the software testing process, from ensuring traceability and software validation to scaling regression testing and supporting continuous testing across platforms.
- TestResults
- Tricentis Tosca
- Ranorex
- Appium
- Smartbear
1. TestResults
TestResults is a test automation tool for medical devices and medical software. It is designed for QA teams, developers, and MedTech companies that need to test complex systems under strict regulatory requirements. The tool complements manual testing with automated, human-like testing that produces reliable test results and full compliance documentation.
TestResults helps users run functional testing, regression testing, and reliability testing across operating systems, mobile apps, and web applications. It supports scenarios like iframes, browser tab switching, and multi-factor authentication, making it easier to achieve higher test coverage while reducing human error.
This makes TestResults a user-friendly choice for MedTech teams that need to validate medical device software, improve product quality, and meet IEC 62304 and FDA standards.
Best for
End-to-end automation in medical device software testing where compliance, traceability, and risk reduction are non-negotiable.
Pros
- Built for regulated industries with full compliance documentation and software validation support.
- Automates complex test cases like iframes, browser tab switching, and multi-factor authentication.
- Reduces manual testing, saving time and lowering the risk of human error.
- Provides complete traceability from requirements to test results.
- Works across operating systems, mobile apps, and web applications for higher test coverage.
Cons
- May be too advanced for teams that do not work with regulated medical devices.
- Requires a clear test automation strategy to get the most benefit.
MedTech use cases
- Creating audit-ready documentation automatically during the software testing process.
- Validating medical device software in line with safety standards and regulatory requirements.
- Supporting continuous testing in modern CI/CD pipelines to speed up the development process.
Why it’s the best choice for MedTech companies
TestResults helps MedTech teams test faster, with more confidence, and without gaps in compliance. It combines automation power with a user-centric design, giving testers the tools they need to ensure patient safety, product quality, and reliable releases every time.
2. Tricentis Tosca
Tricentis Tosca is a model-based test automation tool that helps teams automate functional testing, regression testing, and integration testing without relying heavily on scripting. It is widely used in industries that require large-scale software testing processes, including healthcare and medical device software development.
Best for
Large QA teams that need model-based test automation across enterprise-scale systems, including medical device software and other systems used in healthcare IT.
Pros
- Uses a model-based approach, reducing the need for source code scripting.
- Supports functional testing, regression testing, and integration testing across multiple platforms.
- Good at handling continuous testing in CI/CD pipelines.
- Can increase test coverage quickly for teams running complex software testing processes.
Cons
- Less specialized for medical devices compared to tools built specifically for regulated environments.
- Can be time-consuming to configure and maintain for MedTech use cases.
- Heavy platform with a steeper learning curve for smaller teams.
MedTech use cases
- Automating regression testing for large-scale medical software projects.
- Integrating with existing software development and test management systems.
- Supporting documentation needs by linking test cases to requirements, though compliance reporting often needs customization.
3. Ranorex
Ranorex is a test automation tool focused on UI-level testing for desktop, web, and mobile apps. It is popular with QA teams because it offers a record-and-playback feature that allows testers to create test cases without deep coding knowledge.
Ranorex supports functional testing, regression testing, and cross-browser validation, making it a versatile option for improving test coverage across different operating systems and applications.
Best for
Small to mid-sized teams looking for a user-friendly test automation tool to cover desktop, web, and mobile apps in medical software projects.
Pros
- Strong support for UI-level functional testing and regression testing.
- Works across operating systems, web applications, and mobile apps.
- Record-and-playback feature helps non-developers create and maintain test cases.
- Integrates with popular CI/CD tools for continuous testing.
Cons
- Limited scalability for enterprise-level medical devices testing.
Not purpose-built for compliance-heavy environments; compliance documentation needs customization. - Test maintenance can become time-consuming with complex software development workflows.
MedTech use cases
- Automating UI-level test cases for medical device software with graphical user interfaces.
- Running cross-browser and cross-platform regression testing to ensure product quality.
- Supporting testers with limited programming skills in building automated checks.
- Validating smaller components of medical devices or companion mobile apps, though not ideal for full regulatory traceability.
4. Appium
Appium is an open-source test automation tool designed primarily for mobile apps and hybrid applications. It allows testers to run automated functional testing and regression testing across Android and iOS without needing access to the app’s source code.
Because it works at the UI level, it can simulate real user interactions, making it a practical choice for teams validating medical device software that depends on mobile connectivity.
Best for
Testing mobile apps and hybrid applications connected to medical devices where open-source flexibility is needed.
Pros
- Open-source and free to use, with strong community support
- Excellent for automating functional testing and regression testing on iOS and Android
- Works across different operating systems and device types
- Flexible architecture allows integration into CI/CD pipelines for continuous testing
Cons
- Not designed specifically for regulated industries; lacks built-in compliance documentation and software validation features.
- Setup and configuration can be time-consuming for complex medical software projects.
- Requires programming skills; not as user-friendly for non-technical testers.
- Limited support for desktop or embedded medical devices outside of mobile apps.
MedTech use cases
- Automating test cases for companion mobile apps that connect with medical devices.
- Running reliability testing and regression testing across multiple device types and OS versions.
- Supporting the development process of mobile-driven medical device software, though compliance tasks need to be handled outside the tool.
- Validating data security and non-functional requirements in mobile app workflows, but requiring additional solutions for full risk management and traceability.
5. Smartbear
SmartBear offers a suite of automated testing tools such as TestComplete, ReadyAPI, and Zephyr, which can be used for functional testing, regression testing, and performance testing. These tools are designed to improve test coverage across desktop, web, and API layers, making them flexible for different parts of the software testing process.
Best for
General-purpose test automation across desktop, web, and API layers where compliance isn’t the primary concern.
Pros
- Wide toolset (TestComplete, ReadyAPI, Zephyr) covering desktop, web, and API testing.
- Improves test coverage across different application layers.
- Strong support for integration with test management and CI/CD pipelines.
- Flexible enough to adapt to various software development environments.
Cons
- Not specialized for medical devices; lacks built-in compliance documentation or software validation features.
- Multiple tools can increase complexity and time-consuming setup.
- Requires skilled testers and developers to configure effectively.
MedTech use cases
- Running functional testing and regression testing on backend systems that interact with medical device software.
Validating APIs for data security and interoperability with other systems in healthcare environments. - Using Zephyr for test management and traceability of test cases, though compliance reporting needs customization.
- Supporting continuous testing in enterprise-level MedTech projects, but requiring additional frameworks for full regulatory requirements.
Frequently asked questions
What is the best automated testing tool for MedTech companies?
The best automated testing tool for MedTech companies is TestResults. It is designed for regulated industries and built to handle the strict regulatory requirements of medical device software.
TestResults produces audit-ready compliance documentation, supports software validation, and reduces human error through automated, human-like testing. For MedTech teams, this means safer devices, proven patient safety, and reliable test results.
Why is TestResults better than Tricentis Tosca for MedTech companies?
TestResults is better than Tricentis Tosca for MedTech companies because it is designed specifically for regulated industries. While Tosca is a capable enterprise test automation tool, it was not built with medical devices in mind.
TestResults automates IQ/OQ, ensures full traceability from requirements to test cases, and generates the compliance documentation auditors expect. This makes it easier for MedTech companies to meet IEC 62304 and FDA regulations without heavy customization.
Is Ranorex the best MedTech software testing tool?
Ranorex is a useful tool for UI-level functional testing and regression testing, but it is not the best choice for MedTech. It was not designed for regulated industries and lacks built-in support for compliance documentation or software validation.
The best tool for MedTech companies is TestResults, because it combines automated, human-like testing with the compliance and traceability needed to meet strict safety standards like IEC 62304.
Ready to choose the right automation testing tools for medical software?
Picking the right test automation tool for medical devices is about more than speed. It’s about compliance, patient safety, and making sure every release of your medical software is reliable. Tools like Tosca, Ranorex, Appium, and SmartBear can support parts of the testing process, but they are not designed for regulated industries. TestResults is, and that’s why it’s the best choice for MedTech companies.
Want to go deeper? Check out our Testing Cheatsheet. It gives you practical steps to improve your test automation strategy, increase test coverage, and stay compliant.
