Integrated Risk Based Design and Global Regulatory Harmonization for Class IIb Medical Devices. International Research Journal on Advanced Engineering Hub (IRJAEH), [S. l.], v. 4, n. 03, p. 1204–1212, 2026. DOI: 10.47392/IRJAEH.2026.0169. Disponível em: https://irjaeh.com/index.php/journal/article/view/1415.. Acesso em: 1 may. 2026.