10 Principles of FDA Software Validation

Purpose

The FDA outlines general principles that should be applied to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.

Scope

The FDA outlines acceptable elements of software validation. However, these recommendations are not the extent of proper compliance. There are many other activities and tasks that must be completed in order to be compliant. It is each manufacturer’s responsibility to be aware of these.

The FDA’s guidelines integrate software life cycle management and risk management activities. The FDA does not recommend specific life cycle models, techniques, or methods. Instead, emphasis is placed on software validation and verification activities that are conducted throughout the entire software life cycle.

Off-the-shelf software developers may not be directly responsible for ensuring FDA compliance. Therefore, it is the responsibility of the manufacturer to verify that the software is validated for intended use.

To read the rest of our paper on FDA software validation, download our free article here.