A new approach for medical device product documentation

Sammanfattning: Hardware and software developers rely on different tools for document management, product data management (PDM) and software configuration management (SCM). As more and more products include components of both types there is a growing demand for one collaborative system. This becomes even more critical in the medical sector, where a device is under regulatory demands for document management to even be allowed in to the market. Combined systems become more complex and are generally based on PDM-principles rather than SCM. Current development of SCM tends instead towards simpler systems focused on pure version control (VCS) that are easy to use and economically available to small- and medium sized enterprises (SME), which is not the case with generic PDM-systems or combined systems. This study explored the possibility to extend the usage of such a VCS and include hardware documentation as well as software. The aim was to further our understanding of the SME perspective on product documentation for the medical device field. The method was a case study, collaboration with a SME development company. The scope was to explore possible usage of a chosen VCS (GitLab) and to compare it with a generic PDM-system and with existing manual system. The results showed that for several of the hardware document types there are special made Git-solutions to find within the open source community. However, none of the ones tested in the study was deemed good enough with respect to functionality and reliability. Instead the case study used direct storage of the files in their binary format and focused on testing different VCS functions and on how to organize in order to best gain the advantages of using the system. The conclusions showed that hardware documents can be stored in the same iterative manner as software but with limited Git functionality. Compared with a PDM system GitLab can offer the same level of revision control and communication around the specifications but lacks classification of parts and detailed product structures. GitLab offers better iteration history than both a PDMsystem and the existing manual system does. But not being able to use full Git functionality the organization needs a collaboration strategy to handle the decentralized storage. If the collaboration strategy matches the organization development practices, GitLab is a useful alternative for medical device documentation.