Loading...
Publication
Marcação CE de dispositivos médicos e segurança em software
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 2.65 MB | Adobe PDF |
Authors
Advisor(s)
Abstract(s)
Com o crescente aumento da Teleradiologia, sentiu-se necessidade de criar mais e
melhores softwares para sustentar esse crescimento. O presente trabalho pretende
abordar a temática da certificação de software e a sua marcação CE, pois para dar
entrada no mercado Europeu todos os Dispositivos Médicos (DM) têm de estar devidamente
certificados. Para efetuar a marcação CE e a certificação serão estudadas
normas e normativos adequados para marcação de DM ao nível Europeu e também
dos Estados Unidos da América. A temática da segurança de dados pessoais será
também estudada de forma a assegurar que o dispositivo respeite a legislação em
vigor. Este estudo tem como finalidade a certificação de um software proprietário da
efficientia sysPACS, um serviço online abrangente, que permite a gestão integrada
do armazenamento e distribuição de imagens médicas para apoio ao diagnóstico.
With the increasing use of tele-radiology, it is necessary to develop more and better software to support this growth without compromising security and safety. This study addresses the software certification in general and the CE label in particular, because all medical devices related software to be used in the European market must be a priori certified. To achieve CE label and software process certification, legislation, standards and good-practices associated with medical devices in Europe and in the United States of America will be identified and analyzed. The subject of personal data security will be addressed in order to ensure that the medical device complies with current legislation. This study aims at the certification of proprietary software from Efficientia (sysPACS), a comprehensive online web-based information system supporting an integrated storage management and the distribution of medical data for diagnostic purposes.
With the increasing use of tele-radiology, it is necessary to develop more and better software to support this growth without compromising security and safety. This study addresses the software certification in general and the CE label in particular, because all medical devices related software to be used in the European market must be a priori certified. To achieve CE label and software process certification, legislation, standards and good-practices associated with medical devices in Europe and in the United States of America will be identified and analyzed. The subject of personal data security will be addressed in order to ensure that the medical device complies with current legislation. This study aims at the certification of proprietary software from Efficientia (sysPACS), a comprehensive online web-based information system supporting an integrated storage management and the distribution of medical data for diagnostic purposes.
Description
Keywords
Certificação de software Marcação CE Segurança de dados Dispositivos médicos DICOM PACS HL7 Software certification CE label Data security Medical devices
Citation
Publisher
Instituto Politécnico do Porto. Instituto Superior de Engenharia do Porto