KUBERAN S; KAMARAJ R. Regulatory Frameworks for Orphan Medical Device: A Comparative Review of USFDA and EU Approaches. The Bioscan, [S. l.], v. 20, n. Special Issue-3, p. 286–293, 2025. DOI: 10.63001/tbs.2025.v20.i03.S.I(3).pp286-293. Disponível em: https://thebioscan.com/index.php/pub/article/view/3882. Acesso em: 29 dec. 2025.