ISO 13485 – Medical Devices.

ISO 13485 Medical devices  Quality management systems — Require for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.


  • Increased quality of product/services.
  • Decreased operational cost.
  • Decreased production loss rate.
  • Increased customer satisfaction.
  • Increased efficiency.
  • Minimize mistakes.