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

Eduardo Carvalho   1 * , MSc ;   Miguel Mascarenhas   2, 3, 4 * , PhD ;   Francisca Pinheiro   5 , MSc ;   Ricardo Correia   5 , BSc ;   Sandra Balseiro   6 , MSc ;   Guilherme Barbosa   1 , MSc ;   Ana Guerra   1 , PhD ;   Dulce Oliveira   1 , PhD ;   Rita Moura   1 , PhD ;   André Martins dos Santos   2, 5 , MD ;   Nilza Ramião   1 , PhD

1 Institute of Science and Innovation in Mechanical and Industrial Engineering (INEGI), Porto, Portugal

2 Faculty of Medicine, Universidade do Porto (FMUP), Porto, Portugal

3 Hospital de São João, Porto, Portugal

4 University of South Alabama, Mobile, AL, United States

5 BioGHP, Lisboa, Portugal

6 SmartMDR, Coimbra, Portugal

*these authors contributed equally

Corresponding Author:

  • Eduardo Carvalho, MSc
  • Institute of Science and Innovation in Mechanical and Industrial Engineering (INEGI)
  • Campus da FEUP Rua Dr. Roberto Frias, 400
  • Porto 4200-465
  • Portugal
  • Phone: +351 229578710
  • Email: ecarvalho@inegi.up.pt