This paper is in the following e-collection/theme issue:

Viewpoints and Perspectives in AI (16) General Original Articles (8) Journal Club CATCH-IT Reports* (6) Epublishing and Open Access (104) General Original Articles (8)

Published on in Vol 4 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/76854, first published .
Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Authors of this article:

Eduardo Carvalho1 Author Orcid Image ;   Miguel Mascarenhas2, 3, 4 Author Orcid Image ;   Francisca Pinheiro5 Author Orcid Image ;   Ricardo Correia5 Author Orcid Image ;   Sandra Balseiro6 Author Orcid Image ;   Guilherme Barbosa1 Author Orcid Image ;   Ana Guerra1 Author Orcid Image ;   Dulce Oliveira1 Author Orcid Image ;   Rita Moura1 Author Orcid Image ;   André Martins dos Santos2, 5 Author Orcid Image ;   Nilza Ramião1 Author Orcid Image
Article Authors Cited by (1) Tweetations Metrics

Journals

  1. Almarie B, Gonzalez-Gonzalez L, dos Santos Barbosa L, Lutz A, Grosse U, Fregni F. Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting. Biomedicines 2025;13(12):3005 View