Software Validation Study
Producers that produce a medical device which consists of a software must finalize the software validation study in accordance with the EN 62304 Standard.
Medical device producers should ensure the proper operation of the software available on the medical device and validate the operation suitability of the software before releasing the product on the market.
It Is extremely important to understand the following definitions in order to complete this study correctly.
- Software Unit: Every software code that enables the execution of the functions that are expected from the software, forms the software unit. The software units are the smallest part of a software and are not subdivided.
- Software Item: The software item is the software code ensemble which is a result of the unification of software units. The software items form the software units by dividing the software items into subdivisions.
- Software Development Life-Cycle: The software development life-cycle is all the stages that a software goes through from the planning of the project to the delivery and until the software is pulled from the market.
In order to carry out the validation study, the Software Development Life-Cycle should be identified thoroughly.
The software life-cycle process for the medical device software should be examined under 5 main headings;
- Software Development Process
- Software Risk Management Process
- Software Configuration Management and Change Control Process
- Software Problems Solution Process
- Software Maintenance Process