Mozarc
Optimization and Simplification of Mozarc Medical’s Design Control Quality Management System (QMS)
Students Amritta Balaji, Megan Birenbaum, Devon Cooper, Anabel Likoskendaj, Alvin Villarosa
Corporate Liaisons Barbara Lancini, Emir Osmanagic, Alessio Marconi, Andrea Civitareale
Faculty Advisor Nazia Rashid
Mozarc Medical (MM) is revolutionizing kidney health with innovative, patient-centered technology. As an independent company, MM enhances patient experiences and expands global access to care, driving improved outcomes.
Following its transition from Medtronic, MM successfully migrated quality procedures and launched the TMP Project to modernize and optimize its quality systems. This initiative ensures compliance with global standards, enhances development efficiency, and right-sizes the quality management system to MM’s needs. Digital transformation remains central to MM’s vision, reinforcing innovation and operational excellence.
A key goal of the TMP Project was to streamline documentation, including policies, procedures, work instructions, and templates. MM leveraged AI tools to reduce redundancy and optimize procedures, enhancing its quality management system. The team mapped, reorganized, and refined processes to align with MM’s framework, improving clarity and efficiency. Additionally, cross-functional collaboration was crucial in ensuring the seamless integration of new methods and tools.
Success criteria include integration metrics, increased efficiency, AI effectiveness, and its impact on staff performance. The project also explores tools like Jama and Enterprise Architect to enhance traceability and simplify workflows, ensuring robust regulatory compliance.
By refining its quality systems, MM is building a future-ready framework that ensures compliance, improves efficiency, and strengthens its leadership in kidney health innovation. This transformation underscores MM’s commitment to reshaping kidney care through advanced technology, streamlined operations, and a continuous drive for excellence in patient care.



