An electronic post market surveillance system for medical devices

Vlachos, I; Kalivas, D; Panou-Diamandi, O

dc.contributor.author	Vlachos, I	en
dc.contributor.author	Kalivas, D	en
dc.contributor.author	Panou-Diamandi, O	en
dc.date.accessioned	2014-03-01T01:18:38Z
dc.date.available	2014-03-01T01:18:38Z
dc.date.issued	2003	en
dc.identifier.issn	0169-2607	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/15123
dc.subject	CORBA	en
dc.subject	Medical devices	en
dc.subject	Post market surveillance	en
dc.subject	Public-private key cryptography	en
dc.subject	UMDNS	en
dc.subject	XML	en
dc.subject.classification	Computer Science, Interdisciplinary Applications	en
dc.subject.classification	Computer Science, Theory & Methods	en
dc.subject.classification	Engineering, Biomedical	en
dc.subject.classification	Medical Informatics	en
dc.subject.other	Health care	en
dc.subject.other	Marketing	en
dc.subject.other	Public key cryptography	en
dc.subject.other	Societies and institutions	en
dc.subject.other	Standards	en
dc.subject.other	User interfaces	en
dc.subject.other	XML	en
dc.subject.other	Medical devices	en
dc.subject.other	Biomedical equipment	en
dc.subject.other	article	en
dc.subject.other	cost	en
dc.subject.other	device	en
dc.subject.other	electronics	en
dc.subject.other	health care industry	en
dc.subject.other	health survey	en
dc.subject.other	medical assessment	en
dc.subject.other	standard	en
dc.subject.other	task performance	en
dc.subject.other	Equipment and Supplies	en
dc.subject.other	Pilot Projects	en
dc.subject.other	Product Surveillance, Postmarketing	en
dc.subject.other	User-Computer Interface	en
dc.title	An electronic post market surveillance system for medical devices	en
heal.type	journalArticle	en
heal.identifier.primary	10.1016/S0169-2607(02)00060-3	en
heal.identifier.secondary	http://dx.doi.org/10.1016/S0169-2607(02)00060-3	en
heal.language	English	en
heal.publicationDate	2003	en
heal.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. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.	en
heal.publisher	ELSEVIER SCI IRELAND LTD	en
heal.journalName	Computer Methods and Programs in Biomedicine	en
dc.identifier.doi	10.1016/S0169-2607(02)00060-3	en
dc.identifier.isi	ISI:000183435000004	en
dc.identifier.volume	71	en
dc.identifier.issue	2	en
dc.identifier.spage	129	en
dc.identifier.epage	140	en