Requirements specification for a harmonized medical device vigilance information exchange system.
Effective and efficient medical device vigilance information exchange requires addressing several organizational and technical issues in a harmonized way. This paper describes a conceptual data model that has been derived within the scope of the EUROMEDIES project and accepted by project participants as a meaningful representation of data requirements on medical device vigilance. A possible scenario of a distributed implementation of the model is also discussed.
Vassilacopoulos
G
G
Department of Informatics, University of Piraeus, Greece.
D003199:Computer Systems; D004869:Equipment Safety; D004864:Equipment and Supplies; D005062:European Union; D007256:Information Systems / Q000458:organization & administration; D008962:Models, Theoretical; D011358:Product Surveillance, Postmarketing