The technical documentation (TD) according to the new European regulation, Medical Device Regulation (MDR), is demanding and contains many documents that the manufacturer needs for the market access of a medical device. These are often combined in paper form as individual documents to form a file. These documents are created electronically, e.g. in MS Word or similar, and often entered into a document management system as PDF files. Due to the multiple use, asynchronies of these contents occur again and again. The division of work and signature management is also a great challenge.
Therefore, a fully digital, technical documentation according to MDR should now be possible. Methods and tools, such as source code versioning, LaTeX, Polarion, Bitbucket, Jira etc. are analysed and new concepts for an application are created, which should enable this fully digital, technical documentation according to MDR. The user should be guided without having to understand everything in detail, the usability should be maximum, so that the focus is not on learning a new software, but on working with it effectively. Proof of concepts are also created, tested and first prototypes are created.
