Medical Device Validation & Verification

 Ensure that your healthcare devices and equipment run efficiently, with minimal errors and all usability specifics are fulfilled.

Who We AreA team of highly-skilled medical software developers

The SMEDIX team understands the technical functionality of medical processes, and can help your healthcare business properly evaluate risks by providing the necessary software.

Our ServicesWe use five types of testing in our verification and validation process

Performance Testing

This is the process used for testing the response time, speed, stability and scalability of a medical software application.

Compliance Testing

Determine whether your medical product or services is up to its initial technical standards and complies with regulations.

Interoperability Testing

Check whether you can interact with other software components and systems.

Behaviour Testing

Behavioural, or black-box testing, refers to the type of testing that determines the functionality of your product.

Reliability Testing

See if your software is bug-free and reliable by performing select operations to identify any reliability issues.

Our ProcessWe tackle the verification and validation process in 4 distinct phases

We run constant tests from early development stages and verify results to make sure that every product runs as smoothly as possible. We break down the verification and validation process in 4 distinct phases.

The analysis phase

In this primary phase, we determine the type of medical device we’re testing and its regulatory compliance needs, we create a validation plan and inspect design qualifications and risk impact assessment, as well as look at the metrics framework.

The development phase

With the validation plan finalized, we start the second phase with protocol development, tests, SOP development, and more. We also continue to improve our validation approach and collaborate with you, the client, on further requirements.

The delivery phase

Once a medical device is ready for use, we up the verification and validation tests, review test results and create a summary report of the entire process. We then move on to the final phase.

The maintenance phase

We keep an eye on our products even after implementation. Our team constantly tests the software, runs risk and impact assessments, implements new changes if required, and much more.

Build Reliable Software For Your Business


Our Headquarters

6725 Mesa Ridge Road, Suite 150, San Diego, CA 92121
+1 (619) 571-7655 or +1 (858) 246-6055
+1 (858) 246-6062