Methods for Preclinical Validation of Software as a Medical Device

Alice Ravizza, Federico Sternini, Alice Giannini, Filippo Molinari

2020

Abstract

Software as a medical device is subject to dedicated regulatory requirements before it can be used on human beings. The certification process in Europe requires that sufficient data on clinical benefits are available before the device is CE marked. This position paper describes our proposal of a risk-based approach to technical and preclinical validation of software as medical devices. This approach ensures that all technical solutions for safety are implemented in the software and that all information for safe use is consistent before the software can be made available to patients. This approach is compliant to the main international standards ISO 13485 on quality systems and ISO 14971 on risk management and therefore ensures regulatory compliance as well as patient protection. This integrated approach allows the designers of the software to integrate regulatory and safety testing in the technical testing of the candidate release version of the device. This approach ensures patient safety and regulatory compliance at the same time as technical functionality.

Paper Citation

in Harvard Style

Ravizza A., Sternini F., Giannini A. and Molinari F. (2020). Methods for Preclinical Validation of Software as a Medical Device. In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 5: HEALTHINF; ISBN 978-989-758-398-8, SciTePress, pages 648-655. DOI: 10.5220/0009155406480655

in Bibtex Style

@conference{healthinf20,
author={Alice Ravizza and Federico Sternini and Alice Giannini and Filippo Molinari},
title={Methods for Preclinical Validation of Software as a Medical Device},
booktitle={Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 5: HEALTHINF},
year={2020},
pages={648-655},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0009155406480655},
isbn={978-989-758-398-8},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 5: HEALTHINF
TI - Methods for Preclinical Validation of Software as a Medical Device
SN - 978-989-758-398-8
AU - Ravizza A.
AU - Sternini F.
AU - Giannini A.
AU - Molinari F.
PY - 2020
SP - 648
EP - 655
DO - 10.5220/0009155406480655
PB - SciTePress