{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T21:58:49Z","timestamp":1774735129028,"version":"3.50.1"},"reference-count":53,"publisher":"Emerald","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The medical devices industry has many small businesses with innovation potential, and managing risks is a crucial process required by the different regulations applied to them. In this context, this research aims to investigate the risk-management practices of technology-based small and medium-sized enterprises (SMEs) in the sector, to identify characteristics and possible difficulties in structuring and carrying out the process, providing support based on literature discussions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design\/methodology\/approach<\/jats:title>\n                    <jats:p>The authors adopted a qualitative methodology based on a multiple case study. The exploratory research included six Brazilian and five Portuguese companies from the medical devices sector, whose risk-management approaches were described and analyzed through semi-structured interviews. The interviews were conducted with experts who work in companies\u2019 quality management systems.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings<\/jats:title>\n                    <jats:p>The results suggest that different risk-management methods can be applied to products regardless of their risk classification. There is a need for continuous employee training in risk-management techniques, as previous experience tends to impact overcoming implementation challenges. It was also identified that, especially in Brazil, the auditors\u2019 risk-management analysis is subjective and that more standardization of audits of medical device companies\u2019 quality management systems should be considered.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Originality\/value<\/jats:title>\n                    <jats:p>The study emphasizes the development of a structured systematic for implementing risk-management processes, which is especially beneficial for SMEs. The case studies provide practical knowledge for other companies to evaluate risk-management practices. Although the results cannot be generalized, this original research supports the existing gaps and excites new discussions in the field.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1108\/ijqrm-10-2024-0356","type":"journal-article","created":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T07:53:05Z","timestamp":1750837985000},"page":"59-81","source":"Crossref","is-referenced-by-count":1,"title":["Risk management as a crucial and challenging process for medical devices SMEs: evidence from a multiple case study on Brazilian and Portuguese startups"],"prefix":"10.1108","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7582-7876","authenticated-orcid":true,"given":"Yasmin Silva Martins","family":"Xavier","sequence":"first","affiliation":[{"name":"Institute of Production Engineering and Management (IEPG), UNIFEI , ,","place":["Itajuba, Brazil"]},{"name":"Department of Production (DPD), School of Engineering and Sciences (FEG), Sao Paulo State University (UNESP) , ,","place":["Guaratingueta, Brazil"]}]},{"given":"Carlos Eduardo Sanches","family":"da Silva","sequence":"additional","affiliation":[{"name":"Institute of Production Engineering and Management (IEPG), UNIFEI , ,","place":["Itajuba, Brazil"]}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0879-1084","authenticated-orcid":true,"given":"Paulo","family":"Sampaio","sequence":"additional","affiliation":[{"name":"UMinho Department of Production and Systems, , ,","place":["Braga, Portugal"]}]},{"given":"Juliana Helena Daroz","family":"Gaudencio","sequence":"additional","affiliation":[{"name":"Institute of Production Engineering and Management (IEPG), UNIFEI , ,","place":["Itajuba, Brazil"]}]}],"member":"140","published-online":{"date-parts":[[2025,6,26]]},"reference":[{"key":"2025122305423830100_ref001","unstructured":"Abimo\n           (2020), \u201cDados econ\u00f4micos\u201d, available at:\u00a0https:\/\/abimo.org.br\/dados-do-setor\/dados-economicos\/ (accessed\u00a010 July 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