Verification is the process of checking at each stage whether the design output conforms to the input requirements for that design stage. After successful verification of all of the design stages, validation is performed to ensure that each requirement has been met.

Verification is conducted throughout the device design process and is done under every stage.

More Comprehensive

Verification becomes more comprehensive as the design process progresses, and as more is learned about the design.

Verification involves tests, inspections and analyses to establish conformance with the design input requirements.

General Rules

There are some general rules and tools that may be utilized in verification activities.

These tools may include:

• Failure modes and effect analyses
• Fault tree analysis
• Integrity testing
• Biocompatibility testing
• Bioburden or endotoxin testing
• Thermal analysis
• Evaluating worst case scenario’s
• Comparison to design activities of a previous similar product