title: An electronic post market surveillance system for medical devices.
abstract: An important issue in the health care sector is the collection of information about adverse incidents relative to medical devices and the exchange of this information among Health Care Institutions, Manufacturers and Competent Authorities. We present an Electronic Post Market Surveillance System, which solves in an efficient and secure way the above problem and it is compliant to the International Standards. The system consists of the PMS Server Application installed in the manufacturers/suppliers premises and the PMS Client Application installed in the Health Care Institutions. The PMS applications are used for the management of the PMS Reports and Responses with important features such as the user-friendly interfaces, interoperability and different implementations depending on the performance and cost requirements. The messages are in XML format and the security is based on public-private key cryptography. The system was evaluated in a systematic way by a variety of users, who were satisfied by the system functionality and efficiency.
authors.affiliation: Department of Electrical and Computer Engineering, Biomedical Engineering Laboratory, National Technical University of Athens, 9 Iroon Polytechniou Str., GR-15773 Zografou, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Vlachos
authors.forename: D
authors.initials: D
authors.lastname: Kalivas
authors.forename: O
authors.initials: O
authors.lastname: Panou-Diamandi
mesh_terms: D004864:Equipment and Supplies; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing; D014584:User-Computer Interface