Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the user needs are met in a medical device in both ISO,FDA. A successful validation process would clearly define inputs and user needs to ensure that a product is properly validated.
ISO standards in regulating medical devices is easier and less confusing for medical device industry.Also, ISO regulations revised somehow, to be easier than FDA.