ISO 13485:2016 Medical Devices - Quality Management System
Trust is crucial when it comes to medical devices. ISO 13485, the international standard for quality management systems of medical devices, supports achieving this by examining the quality management practices of medical devices. The standard focuses on the processes of design, development, production, servicing, and installation.
Certification can demonstrate the reliability and high standards of processes, giving a competitive advantage over peers.
Certification can also be a prerequisite for selling products in other international markets.