How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device-Reference-Cited by-同舟云学术

How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as medical device

Published:2021-10-20 Issue:11 Volume:18 Page:1117-1121
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Barbieri Carlo¹,Neri Luca¹,Chermisi Milena¹,Bolzoni Elena¹,Cattinelli Isabella¹,Decker Wolfgang²,Stuard Stefano³,Martín-Guerrero José D.⁴^ORCID,Mari Flavio¹

Affiliation:

1. Operation and Digital Strategy, Fresenius Medical Care, Bad Homburg, Germany

2. QREM (Quality, Regulatory Affairs & Management Systems), Fresenius Medical Care, Bad Homburg, Germany

3. Global Medical Office, Fresenius Medical Care, Bad Homburg, Germany

4. Intelligent Data Analysis Laboratory, Department of Electronic Engineering, ETSE–UV, Universitat de Valéncia, Burjassot, Valencia, Spain

Funder

Fresenius Medical Care

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2021.1990037

Reference27 articles.

1. Reasoning Foundations of Medical Diagnosis

2. The practical implementation of artificial intelligence technologies in medicine

3. Artificial intelligence, bias and clinical safety

4. IMDRF Software as a Medical Device (SaMD) Working Group “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations. International Medical Device Regulators Forum 2014. Accessed 2020 Oct 15. URL: www.imdrf.org

5. UK Department of Health and Social Care. Code of conduct for data-driven health and care technology. February 2019. 2020 Oct 15. URL: https://www.gov.uk/government/publications/code-of-conduct-for-data-driven-health-and-care-technology/initial-code-of-conduct-for-data-driven-health-and-care-technology

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2. The Use of Anemia Control Model Is Associated with Improved Hemoglobin Target Achievement, Lower Rates of Inappropriate Erythropoietin Stimulating Agents, and Severe Anemia among Dialysis Patients;Blood Purification;2024

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