An effective Quality Management System (QMS) ensures a quality-oriented, compliant and efficient organization culture. The QMS is the foundation for any device manufacturer's success. We have deep experience assessing, revising, and implementing ISO 13485 compliant QMS's for a wide range of medical product categories.
Whether you need a comprehensive QMS tailored to your medical product needs, or you need to refresh your existing QMS to meet updated or new regulations, we have deep expertise to assist you along the way. We have numerous partners that offer world-class eQMS's that meet FDA and international standards, and we have helped many customers update and customize their policies and processes to gain compliance, efficiency and a competitive advantage.