Your medical device can’t take a sick day.

Medical device failure can trigger expensive FDA recalls, jeopardize patient/operator safety and endanger life itself. Our rigorous Verification & Validation processes and software testing are your best protection.

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HOW WE CAN HELP YOU

We’ll deliver safe devices at healthy savings.

Through innovation, superior resources and testing expertise, we’ll assure top performance for your medical devices without risking your bottom-line health.

Ensure regulatory compliance With FDA, HIPAA, DICOM and HL-7 standards.
Reduce release time-to-market by 20%.
Optimize UX with skilled performance testing.
Heighten security with our shift-left cyber approach.

Qualitest-tested = FDA-approved.

We support world-leading medical device manufacturers, with a renowned specialty in radiology imaging. Benefit from our wide experience to assure the highest levels of performance and business success.

Keep Compliant

Avoid audits, work slowdowns and steep fines through our up-to-the-minute knowledge of the most stringent FDA guidelines, as well as DICOM, HIPAA and HL7 standards.

Speed Up Release Time

Get your device into the hands of the folks who critically need it faster through system-wide implementation of automation.

Reduce The Number Of Tests

Leverage the power of AI and ML with our proprietary risk-based testing tool, Qualisense. Fewer tests = less testing costs.

Drive Peak Performance

Trust us to achieve the higher levels of stability, accessibility and reliability medical devices require, as well as extra protection from accidental shutdown.

mobile application stress testing for telecom app

OUR SOLUTIONS

Failure-proof your medical device with expert testing.

Our quality solutions have supported dozens of leading brands–in fact, medical devices make up our largest US sector. We have a unique understanding of the complexity of medical devices, due to the criticality and integrated ecosystem of hardware and software.

Verification & Validation (V&V)

We not only help you optimize your V&V efforts, but we also specialize in documenting those efforts in a way that will be FDA-compliant.

Performance Testing

We integrate performance engineering into your CI/CD pipeline so bottlenecks are detected early in the SDLC.

Load Testing

We’ll test your device at high loads to ensure reliability, responsiveness and consistent performance at all times.

Usability Testing

We’ll make sure the design and user interface of your medical device satisfies government standards for safety and ease of use–and delivers high customer satisfaction.

Shift-Left Cyber Security

Our cyber engineers build security into every stage of your SDLC to spot vulnerabilities sooner and mitigate risk.

Right-Shore

Our massive global network ensures you’ll find exactly the expertise you need at the most convenient location and the most attractive costs.

From my experience working with the Qualitest team, Qualitest has grown into a powerhouse provider of overall software testing solutions, both in manual testing and in test automation. The very fact that they specialize in software testing only makes them uniquely positioned in this field and distinctly sets them apart from the rest of the competition in the same industry.

Robu Mohammad, Test Manager, Fuji Medical

medical device software application testing expert

OUR CAPABILITIES

What are your goals? We’ll help you succeed.

Explore more about how Qualitest can help you reach your business goals and deliver quality medical devices.

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Discover how you can embrace innovation to drive new value for your organization. Explore new insights. See tangible outcomes.

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Ready to get started?

Put your medical device to the test–the Qualitest. Start your device on the road to peak performance now.

FAQs

Here are some frequently asked questions about medical device software testing.

What is medical device software testing?

Medical device software testing is the process of testing software used in medical devices to ensure that it meets the regulatory requirements, is safe and reliable, and performs as intended. Medical device software is used in a wide range of devices, including diagnostic and monitoring equipment, implantable devices, and software-based medical devices.

Medical device software testing is essential to ensure that the software performs accurately and reliably, and meets the requirements of the medical device regulations, such as the FDA’s 21 CFR Part 11 and IEC 62304. This testing includes verifying that the software meets its intended functionality, user interface testing, integration testing, and system testing. Additionally, medical device software testing includes testing for usability, performance, and security to ensure that the software is user-friendly, performs well, and protects patient data.

The testing of medical device software is critical to ensure that the device is safe for use and will not cause harm to the patient. If medical device software is not tested adequately, it can result in inaccurate readings, incorrect diagnoses, or even harm to the patient. As a result, medical device software testing is heavily regulated and requires specific expertise and knowledge to ensure that the software meets the necessary standards for safety, reliability, and performance.

How is medical device testing performed?

Medical device testing is a rigorous and specialized process that involves a series of steps to ensure that the device is safe, effective, and meets the regulatory requirements.

The following are some of the common steps involved in medical device testing:

Planning: The testing process begins with planning, which involves identifying the regulatory requirements, defining the test objectives, and creating a test plan.
Design and Development: The design and development phase involves developing the medical device, including the software, hardware, and other components. This phase also involves creating the device specifications, design documents, and verification and validation plans.
Verification: Verification involves testing the device at each stage of development to ensure that it meets the specified requirements. This includes testing the software, hardware, and other components to ensure that they perform as intended.
Validation: Validation involves testing the final product to ensure that it meets the intended use and is safe and effective for use by the end-users.
Usability Testing: Usability testing involves testing the device from the user’s perspective to ensure that it is easy to use, safe, and effective for the intended use.
Performance Testing: Performance testing involves testing the device’s performance under various conditions to ensure that it performs as expected and meets the regulatory requirements.
Compliance Testing: Compliance testing involves testing the device to ensure that it meets the regulatory requirements, including FDA and other international standards.
Post-Market Surveillance: Post-market surveillance involves monitoring the device after it has been released to the market to ensure that it continues to meet the safety and performance requirements.

Overall, medical device testing is a complex and iterative process that involves multiple stages and specialized expertise. The testing process is critical to ensure that the device is safe, effective, and meets regulatory requirements.

Why choose Qualitest for medical device testing?

Qualitest is a trusted partner for medical device testing with expertise in regulatory compliance, security, and safety. Their end-to-end testing services include risk assessment, usability testing, and performance testing. Choose Qualitest for accurate and reliable medical device testing.