What is ISO 13485?

ISO 13485 is a quality management system which specifies the requirements for regulatory purposes. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

Benefits of ISO 13485

• To increase access to international markets with certification
• To increase efficiency, cut costs and monitor supply chain performance
• To demonstrate that an organization produces safer and more effective medical devices
• To meet regulatory requirements and customer expectations