Dynamic generation of technical documentation for medical devices

In this paper the concept of a novel software tool for dynamic generation of technical documentation of medical devices is presented. The system is based on a relational database and increases reciprocity between sections of the technical documentation (e.g. intended purpose, classification, risk analysis, verifications and tests) through relational links. An algorithm for semi-automatic classification of medical devices according to Annex IX of the European medical device directive was implemented and experimentally compared to manual classification. The algorithmic classification was significantly faster than manual with an error probability of 0,1%. The results show that algorithmic classification is more than equal to manual classification with the benefit of structured data entry, which can be linked to further sections of the documentation such as risk analysis.