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@article{197583,
        author = {Pranav Anand P},
        title = {A Study on the role and Importance of Quality Management Systems and Regulatory Affairs in Medical device Industry Operations},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {11},
        pages = {5922-5928},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=197583},
        abstract = {The medical device industry operates in a highly regulated environment where product quality, patient safety, and regulatory compliance are closely interconnected. This study investigates the role of Quality Management Systems (QMS) and Regulatory Affairs (RA) in improving operational efficiency, product quality, and compliance performance in medical device organizations. A mixed-method research design was adopted using primary data collected through structured questionnaires from professionals in Quality Assurance, Regulatory Affairs, and Operations, supported by secondary data from ISO 13485:2016, EU MDR 2017/745, India’s Medical Device Rules 2017, and U.S. FDA Quality System Regulation requirements. The findings indicate that organizations with stronger QMS frameworks, particularly those aligned with ISO 13485, demonstrate better issue resolution, stronger quality performance, and improved operational consistency. The results further show that effective coordination between RA and Operations, dedicated RA resources, regular cross-functional meetings, and management support are associated with fewer operational delays. Key challenges identified include documentation burden, conflicting departmental priorities, delayed regulatory involvement, and communication gaps. The study concludes that the integration of QMS and RA into routine operational activities should be viewed not only as a compliance necessity but also as a strategic enabler of operational excellence in the medical device industry.},
        keywords = {Quality Management System, Regulatory Affairs, ISO 13485, medical devices, compliance, operational efficiency.},
        month = {April},
        }