Although the two are similar, they have significant differences. For example, complaint handling and reporting
requirements are integral to the FDA’s quality systems regulation (QSR), but the FDA thinks they are not adequately
addressed in ISO 13485. In this case, conformity to the ISO standard would not suffice to demonstrate conformity
with the QSR and the FDA’s Center for Devices and Radiological Health will not recognize the standard for this
particular purpose.
