Product Validation

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:

• FDA Class I, II and III Requirements.
• CE ( for Europe)
• UL (for electrical/electronic products)

Empower Medical Devices has a wide range of testing equipment and the depth of experience to operate test equipment, such as:

• Thermal environmental chamber testing
• Temperature testing
• Tensile and strength testing
• Pressure tests
• Texture tests
• Visual inspection
• Electrical tests – sub-assembly, insertion loss/return loss
• Fiber optics – insertion loss/return loss, attenuation, geometry, concentricity, end face inspection

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.

Process Validation

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:

• Governance by our APQP process
• A release of a full manufacturing documentation package prior to starting the pilot build
• Proving out the manufacturing processes

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!

Patent & Regulatory Approval

We at Empower Medical Devices will take care of all patent and regulatory matters associated with your design.

1. We conduct patent research, initiate and follow through on patent applications for your device.
2. We determine all of the regulatory approvals and any standards requirements or protocols that will be needed, most notably for the FDA.

Once we’ve identified the requirements and specifications, we build these into the design and production sequences to ensure complete compliance.