ABSTRACT
Finished products, product characteristics, parts or components, and realization processes will be evaluated and proved for their conformity using acceptance activities and validations. Examination activities may be samplings, inspections, tests, observations, or applied controls over processes. Each will generate data that will be validated against the product requirements with the help of criteria. The validation will prove whether the requirements were met and whether the product conforms to them. The data will be gathered and analyzed according to dened methods; that is, statistical or qualitative evaluations. Bear in mind, however, that you will have to justify the method that you chose and relate it to the nature of the medical devices and the realization processes. In other words, there is to be a correlation between the realization processes, the data collected, and the statistical methods you used to analyze them. Employees and personnel that perform these activities will be appropriately trained and qualied.
