Software refactoring for an automatic sample transfer module

The sample transfer module is already used by end customers. The software for the module is to be refactored so that the certification requirements for a 'class II medical device' are met for the US market. Working together closely with the customer and a third company that developed the software and will perform the refactoring, PTA compiles the software requirements in line with IEC 62304. At the end of the project, the customer has a software requirements document that functionally documents the requirements and that is available to the third company as a basis for the software refactoring.