Engineering validation test

An engineering validation test (EVT) is performed on first engineering prototypes, to ensure that the basic unit performs to design goals and specifications.

Tests

Tests may include:

• Functional test (basic)
• Power measurement
• Signal quality test
• Conformance test
• Electromagnetic interference (EMI) pre-scan
• Thermal and 4 corner test
• Basic parametric measurements, specification verification

Importance

Identifying design problems, and solving them as early in the design cycle as possible, is the key to keeping projects on time and within budget. Too often, product design and performance problems are not detected until late in the product development cycle — when the product is ready to be shipped. The old adage holds true: It costs a penny to make a change in engineering, a dime in production and a dollar after a product is in the field.

Prototyping

In the prototyping stage, engineers create actual working samples of the product they plan to produce. Engineering verification testing (EVT) is used on prototypes to verify that the design meets pre-determined specifications and design goals. This valuable information is used to validate the design as is, or identify areas that need to be modified.

Design verification test

Design verification test (DVT) is an intensive testing program which is performed to deliver objective, comprehensive testing verifying all product specifications, interface standards, original equipment manufacturer (OEM) requirements, and diagnostic commands. It consists of the following areas of testing:

• Functional testing (including usability)
• Performance testing
• Climatic testing
• Reliability testing
• Environmental testing
• Mechanical testing
• Mean time between failures (MTBF) prediction
• Conformance testing
• Electromagnetic compatibility (electromagnetic compatibility (EMC)) testing and certification
• Safety certification

Design refinement

After prototyping, the product is moved to the next phase of the design cycle: design refinement. Engineers revise and improve the design to meet performance and design requirements and specifications.

References

External links

• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers, "Design Control Guidance For Medical Device Manufacturers", Section F: "Design Verification".