The completed design is tested for functionality and performance by our expert engineering teams. Performance tests may also have to be conducted to ensure the design meets any regulatory approvals that will be needed, such as for:
Empower Medical Devices has a wide range of testing equipment and the depth of experience to operate test equipment, such as:
Our product testing and validation process may also include conducting studies and clinical trials. We also use outside partners to conduct certain tests, if needed.
We not only test the product for validation, but we also address our processes to manufacture the product. So, at this stage, our process validation involves:
Empower Medical Devices establishes a Quality Assurance program of testing and validation for your medical device project that is integrated into our Stage-Gate and APQP processes. We won’t miss a trick!
We at Empower Medical Devices will take care of all patent and regulatory matters associated with your design.
Once we’ve identified the requirements and specifications, we build these into the design and production sequences to ensure complete compliance.
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