TY - GEN
T1 - Dynamic generation of technical documentation for medical devices
AU - Lueddemann, Tobias
AU - Bebert, Helena
AU - Schiebl, Jonas
AU - Lueth, Tim C.
N1 - Publisher Copyright:
© 2014 IEEE.
PY - 2014/4/20
Y1 - 2014/4/20
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84949927410&partnerID=8YFLogxK
U2 - 10.1109/ROBIO.2014.7090637
DO - 10.1109/ROBIO.2014.7090637
M3 - Conference contribution
AN - SCOPUS:84949927410
T3 - 2014 IEEE International Conference on Robotics and Biomimetics, IEEE ROBIO 2014
SP - 2043
EP - 2048
BT - 2014 IEEE International Conference on Robotics and Biomimetics, IEEE ROBIO 2014
PB - Institute of Electrical and Electronics Engineers Inc.
T2 - 2014 IEEE International Conference on Robotics and Biomimetics, IEEE ROBIO 2014
Y2 - 5 December 2014 through 10 December 2014
ER -