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

Author

Lueddemann, Tobias ; Schiebl, Jonas ; Roppenecker, Daniel ; Klein, Franziska ; Lueth, Tim C.

Author_Institution

Inst. of Micro Technol. & Med. Device Technol., Tech. Univ. Munchen, Munich, Germany

fYear

2015

fDate

18-20 May 2015

Firstpage

1

Lastpage

6

Abstract

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.

Keywords

knowledge based systems; medical information systems; relational databases; software tools; system documentation; knowledge base; logic-based extension; medical device; relational database system; relational software tool; technical documentation; Documentation; Hazards; ISO standards; Manuals; Risk analysis; Software tools; CE Mark; certification; database system; logic-based system; mdd; medical device; technical documentation;

fLanguage

English

Publisher

ieee

Conference_Titel

Product Compliance Engineering (ISPCE), 2015 IEEE Symposium on

Conference_Location

Chicago, IL

Type

conf

DOI

10.1109/ISPCE.2015.7138708

Filename

7138708