Analysis of ISO 13485:2016 requirements and their effects on the medical device industry

Abstract. In this paper, the ISO 13485 standard was evaluated from multiple perspectives, including the reasons for its development, as well as its global applicability, particularly in Europe, the USA, and Canada. However, there is a lack of research regarding the implementation of the standard by leading companies in the medical device (MD) sector, which limits the understanding of its importance and impact. To address this gap, a case study methodology was employed, involving the identification of the top 10 companies in the MD sector, including Medtronic, Johnson & Johnson, Abbott, and Siemens Healthineers. For each company, aspects such as manufactured products, company size, and annual revenues were analyzed. The purpose of this comparative analysis was to determine whether these companies have implemented the ISO 13485:2016 standard and to assess the impact of this implementation on their performance, as well as to observe best practices and other standards implemented alongside it. The study results suggest that implementing ISO 13485:2016 can contribute to improving the performance and competitiveness of companies in the MD sector, facilitating access to international markets and ensuring compliance with industry-specific regulations. However, specific barriers encountered during the implementation process of the standard's requirements, changes in the number of non-conformities after implementation, or increases in the company's reputation were not specifically identified. These aspects require further research to thoroughly evaluate the impact of implementing this standard on various aspects of corporate performance. The current research was conducted based on publicly available online data. Future research needs to contact companies to obtain relevant information about best practices in implementing the standard, as well as about the quantifiable benefits brought about.