Software Validation Study
Manufacturers of medical devices that contain software must complete the Software Validation Study in accordance with the EN 62304 Standard.
Medical Device Manufacturers must ensure that the software in the medical device they manufacture operates correctly and must validate the software’s functionality before releasing the product to the market.
It is crucial to understand the following definitions for the proper execution of this study:
Software Unit: Each software code that ensures the software performs the expected functions forms a software unit. Software units are the smallest parts of a software and cannot be further subdivided.
Software Element: The collection of software code formed by the combination of software units is called a software element. Software elements are divided into subunits to form software units.
Software Development Life Cycle: The entire series of stages that a software project undergoes, from planning to delivery, as well as the cycle from the software’s market introduction to its removal from the market, is referred to as the Software Development Life Cycle.
For the validation study to be conducted, it is necessary to define the Software Life Cycle completely.
For medical device software, the software life cycle process should be examined under five main headings:
- Software Development Process
- Software Risk Management Process
- Software Configuration Management and Change Control Process
- Software Problem Resolution Process
- Software Maintenance Process