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.

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.
Quality Insight
app testing on all devices
blockchain testing solutions
engineer working on software testing

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.
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


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