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Design verification is included among the design control requirements of International Organization for Standardization 9001:2000 Quality Systems Management--Requirements. This involves testing the final product to prove that design output (final design, specifications, and functional performance) meets design input (customer needs and performance requirements) . Medical device companies spend considerable time and effort in the design verification and validation phase of the product development process. Required activities during this phase may include bench testing, animal studies, and human clinical studies. Package testing and shelf-life studies may be part of this phase as well.