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This study aims to develop a novel diagnostic methodology for implementing ISO13485:2016 and test its applicability to improve quality management systems (QMS) in the medical devices industry context.

First, a literature review on the topic was conducted. Second, insights gained from the literature and expert interviews were employed to develop the new maturity assessment methodology. Subsequently, the methodology was tested on a medical device manufacturer. Next, based on the evaluation of the intervention, actions were recommended to improve the QMS.

Research findings have developed a maturity assessment methodology comprising 52 certifiable requirements structured into four macro-requirements derived from ISO 13485:2016. Findings show that the methodology is valuable for aiding QMS implementation, and the diagnosed maturity levels corresponded with the company’s empirical perceptions of the requirement’s maturity.

Empirical evidence validates the significance and practical utility of the proposed methodology, as evidenced by the company’s attainment of FDA (US Food and Drug Administration) approval after the intervention. Findings suggest that the methodology could be replicated within the medical products industry or adapted to assess other QMS, leveraging the organizational alignment with the international regulations of the sector and the ISO 9000 requirements.

The developed methodology fills existing gaps in both literature and practice within the medical devices industry, providing a valuable contribution by addressing the limited research on diagnostic methodologies designed for ISO 13485:2016 implementation. The article assists medical device enterprises in addressing QMS maturity levels as a metric for evaluating QMS requirements, which is an underexplored avenue in existing QMS evaluation approaches.

This paper aims to identify the determining factors for the financial performance (FP) of social enterprises in an emerging country, in this case Brazil.

This paper identifies the determinants of the FP of social enterprises in Brazil using the resource-based view as a theoretical lenses and the quantitative method (n = 601) of logistic regression, analyzing the importance of nine variables related to SEs.

The findings refer to practical contributions (which show how SEs should focus and allocate their resources to maximize FP) and theoretical contributions linked to entrepreneurship literature (by differentiating the results of this work from the literature on commercial entrepreneurship in terms of resources), social entrepreneurship literature (by presenting the resources that determine their FP), business literature, entrepreneurial finance and entrepreneurship in emerging economies.

This work represents a novelty from a methodological point of view, filling the gap regarding the lack of studies that apply a quantitative methodology to a large sample and analyze several different variables when most studies analyze only one factor related to the performance of an organization. It also fills the gap in entrepreneurship studies that use some theoretical lenses. This work is also a pioneer in analyzing the variables involved, such as market orientation, technologies and impact measurement in social entrepreneurship. As this work uses data from a secondary sample, there is the limitation of not choosing the analyzed variables. Even though there were many variables in the sample, it was impossible to consider some variables, referring to various aspects of resources and performance. For this same reason, the social performance of SEs, which is of fundamental importance within the objectives of any organization of this type, was not analyzed and may be a suggestion for future work.