The solution is to create the documentation necessary, especially if it is to be given in technical documentation, to get the right to put a medical device on the market. For a medical device, you have to give the regulatory authority a lot of information, and they go down to the lines of code and to the risk management of this line of code, for this database is needed since it is no more possible to do it with hands. In this case, they outsourced the validation of the software with another company, and they made the software with another company. Polarion was used to extract from the software the information for the regulatory authority.
I worked with a customer to use Polarion. My experience is about the feedback and the output of the tool. It worked, but it wasn't the best one I have evaluated.
Speaking from my experience, I get the feedback of the user, and I get told about the document to be provided in the technical documentation. It's mostly about the report or the reporting. It's also about how to extract the quality data from a huge management report saying that all the software requirements were correctly evaluated from case management. This evaluation is correctly re-evaluated with software for the VnV process. So all of these reports and with software like Polarion, one must be able to get all of these reports with just a click, which is somehow not the case with Polarion, especially with the experience I had. There is a lot of work to be done to complete the documentation needed.