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

Viewpoints and Perspectives in AI (17) General Original Articles (10) Journal Club CATCH-IT Reports* (7) Epublishing and Open Access (107) General Original Articles (10)

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 (3) 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
  2. Naseer F, Naseer U, Yousaf M, Wei J, Gao Y, Li D, Tian X, Liu Y, Li X, Wang F, Luo P. AI-Integrated biosensors: A paradigm shift in multi-cancer detection with enhanced sensitivity and specificity. Sensors and Actuators Reports 2026;11:100439 View
  3. Bailo P, Nittari G, Pesel G, Basello E, Spasari T, Ricci G. Governing Healthcare AI in the Real World: How Fairness, Transparency, and Human Oversight Can Coexist: A Narrative Review. Sci 2026;8(2):36 View