Ensure that your healthcare devices and equipment run efficiently, with minimal errors and all usability specifics are fulfilled.
The SMEDIX team understands the technical functionality of medical processes, and can help your healthcare business properly evaluate risks by providing the necessary software.
This is the process used for testing the response time, speed, stability and scalability of a medical software application.
Determine whether your medical product or services is up to its initial technical standards and complies with regulations.
Check whether you can interact with other software components and systems.
Behavioural, or black-box testing, refers to the type of testing that determines the functionality of your product.
See if your software is bug-free and reliable by performing select operations to identify any reliability issues.
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.
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.
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.
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.
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.