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Authors: Sadra Farshid 1 ; 2 ; Bruno Lima 1 ; 3 and João Faria 1 ; 3

Affiliations: 1 Faculty of Engineering of the University of Porto, Porto, Portugal ; 2 Capgemini Engineering Portugal, Lisbon, Portugal ; 3 INESC TEC, Porto, Portugal

Keyword(s): Medical Device, Software as a Medical Device, Compliance Assessment, Web Platform.

Abstract: Medical devices (MDs) and Software as a Medical Device (SaMD) are essential for e-Health applications, but they must comply with strict standards and regulations to ensure their safety and effectiveness. However, there is a lack of tools to assist in conducting appraisals for compliance assessment and managing appraisal information. In this paper, after reviewing the most relevant standards and regulations for MD and SaMD certification, we propose a web platform to help technology companies that lack expertise in developing SaMD to create compliant and high-quality products for the e-Health market. The platform provides users with custom checklists or questionnaires depending on the selected regulations, standards, risk classes, and product parameters. Supporting a secure, incremental, and collaborative approach to completing the assessment process, the platform enables the attachment of notes, evidence, and improvement suggestions. It facilitates repeated assessments over time for d ata reuse and comparative analysis, enhancing the assessment process’s efficiency and effectiveness. (More)

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Paper citation in several formats:
Farshid, S.; Lima, B. and Faria, J. (2023). Towards Computer Assisted Compliance Assessment in the Development of Software as a Medical Device. In Proceedings of the 18th International Conference on Software Technologies - ICSOFT; ISBN 978-989-758-665-1; ISSN 2184-2833, SciTePress, pages 728-735. DOI: 10.5220/0012148400003538

@conference{icsoft23,
author={Sadra Farshid. and Bruno Lima. and João Faria.},
title={Towards Computer Assisted Compliance Assessment in the Development of Software as a Medical Device},
booktitle={Proceedings of the 18th International Conference on Software Technologies - ICSOFT},
year={2023},
pages={728-735},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0012148400003538},
isbn={978-989-758-665-1},
issn={2184-2833},
}

TY - CONF

JO - Proceedings of the 18th International Conference on Software Technologies - ICSOFT
TI - Towards Computer Assisted Compliance Assessment in the Development of Software as a Medical Device
SN - 978-989-758-665-1
IS - 2184-2833
AU - Farshid, S.
AU - Lima, B.
AU - Faria, J.
PY - 2023
SP - 728
EP - 735
DO - 10.5220/0012148400003538
PB - SciTePress