Advancing quality management in the medical devices industry: strategies for effective ISO 13485 implementation

Int J Qual Health Care. 2025 Feb 3;37(1):mzaf004. doi: 10.1093/intqhc/mzaf004.

Authors

Diego Augusto de Jesus Pacheco¹, Samuel Vinícius Bonato², William Linck³

Affiliations

¹ Produttiva Consulting, Birk Centerpark 15, Canoas 92425-587, Brazil.
² Department of Management, Federal University of Rio Grande-FURG, Av. Itália, km 8-Carreiros, Rio Grande, RS 96203-900, Brazil.
³ Department of Production Engineering, Engineering School, Federal University of Rio Grande do Sul-UFRGS, Praça Argentina, nº 9-Centro Histórico, Porto Alegre, RS 90035-190, Brazil.

PMID: 39834056
DOI: 10.1093/intqhc/mzaf004

No abstract available

Keywords: ISO 13485; ISO 9001; healthcare; medical devices; quality management; quality management system.

Grants and funding

Finance code 001/Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES)