Towards a logic-based extension of a relational software tool for coherent technical documentation of medical devices

This work presents a novel software tool intended to support compilation of coherent technical documentation. It is based on a relational database system serving as knowledge base incorporating information from the European Medical Device Directive and harmonized standards such as ISO 14971, ISO 980 or ISO 10993-x. In order to achieve increased consistency among sections of documentation for medical devices a concept for formal description of technical documentation and an additional logic-based system is presented.