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Viewpoints and Perspectives in AI (21) General Original Articles (9) Epublishing and Open Access (108) Journal Club CATCH-IT Reports* (7)

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 (10) 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
  4. Xu Q, Li Y, Zhu M, Cai Y, Cheng X, Wang W, Ju J, Xu Y, Liu Y, Liu Y. Precision cardiovascular medicine with big data and AI. npj Digital Medicine 2026;9(1) View
  5. Varzideh F, Mone P, Kansakar U, Pande S, Jankauskas S, Santulli G. Artificial Intelligence in Cardiovascular Medicine: Focus on Hypertension. Hypertension 2026 View
  6. Ebrahimi Warkiani M, Safari B, Moattar M, Hosseinzadeh M. A systematic review of multimodal large language models for medical decision support: Architectures, fusion methods, and real-world applications. Applied Soft Computing 2026;196:115051 View
  7. Hong J. Artificial intelligence for optimizing medical laser procedure parameters: a data pipeline, performance metrics, and safety-first framework. Medical Lasers 2026;15(1):20 View
  8. Dinc R, Ardic N. Immunologically Adaptive Endovascular Devices: Integrating Thrombo-Inflammation, Biomaterials Design, and Artificial Intelligence for Precision Cardiovascular Intervention. International Journal of Molecular Sciences 2026;27(8):3493 View
  9. Nandagopal S. Safety Envelopes and Continuous Assurance for Updates and Postmarket Surveillance in Digital Mental Health Technologies. Journal of Medical Systems 2026;50(1) View
  10. Yang X, Ding S, Ren M, Zhang H, Tao X, Zhang N, Zhang Y, Jiange H, Pan Y, Yao S, Wang L, Ma Y, He Y, Yu S, Yu Y, Lyu A, Zhang B, Zhang G. From selection to design: Reshaping aptamer discovery with artificial intelligence. Chemical Engineering Journal 2026;538:176731 View