Quality Management System (QMS) is one of the greatest challenges in the medical device industry today. Certain manufacturers are legally required to work according to a certified QMS (ISO 9001 / ISO 13485). For others, it is simply a measure to indicate reliable, high-quality service. The implementation of QMS is definitely an advantage: customer satisfaction and a certificate confirm well-defined and well-organized processes.
For the QM certificate, the implementation of a custom-made QM-system is required, which needs manufacturer-specific solutions and not mass-produced instructions. Our team, experienced in the medical-device industry and with understanding of medical-device producers’ needs, is ready to assist you with the entire QMS setup and certification.