A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements. Design validation should be more than bench testing. Ensure that animal models, simulated anatomical models, finite element analysis and human clinical studies are considered.

Also, manufacturers of medical devices must validate any process, including any associated equipment and software, whose entire output is not or cannot be fully verified by inspection. Examples of these type of processes are sterilization, packaging systems, soldering processes, and automated systems.Critical processes that may require validation include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage and distribution.