What is ISO 13485 quality management system?

ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices. 

The ISO 13485:2016 benefits includes:

• Outline how to review and improve processes
• Increase efficiency, cut costs and monitor performance
• Demonstrate that you produce safer medical devices
• Meet regulatory requirements and customer expectations