Master thesis by Clara Piris, Quality and Regulatory Affairs Specialist at cosinuss\u00b0<\/em><\/p>\n<\/div> In today\u2019s fast-evolving regulatory landscape, medical device companies, like cosinuss\u00b0, face growing demands for compliance, data accuracy, and process efficiency. Post-Market Surveillance (PMS) – the ongoing monitoring of product safety and performance after market launch – is one of the most complex and resource-intensive components of a Quality Management System (QMS). This challenge is particularly pressing for smaller companies, where resources are often limited, yet regulatory expectations remain high.<\/p>\n<\/div><\/div><\/div><\/div><\/div> This study investigated how automation can enhance QMS processes, with a special focus on PMS. Through hands-on implementation within the company\u2019s quality framework, the research examined how digital tools, structured databases, and automated workflows can reduce manual workload, improve data quality, and strengthen compliance with international standards such as the MDR, ISO 13485, and FDA guidelines.<\/p>\n<\/div><\/div><\/div><\/div><\/div> The master thesis focused on introducing automation across key QMS functions, including:<\/p>\n By replacing spreadsheets and manual documentation with integrated, automated systems, the thesis demonstrated how quality processes can become more reliable, transparent, and scalable.<\/p>\n<\/div><\/div><\/div><\/div><\/div> The implementation of these strategies delivered clear benefits:<\/p>\n The master thesis shows how automation is not just a technological upgrade – it\u2019s a strategic tool for building resilient, future-ready quality systems. The insights gained offer a roadmap for cosinuss\u00b0 – and other medical device companies – looking to modernize QMS while staying agile and compliant in an increasingly regulated world.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\nFocus: Enhancing QMS processes by automation<\/h2><\/div>
Method: What Was Done<\/h2><\/div>
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Key Outcomes: Clear benefits through automation<\/h2><\/div>
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Conclusion: Strategic tool for medical device companies<\/h2><\/div>