Medical Devices – Quality management systems – ISO 13485

Medical Devices – Quality management systems – ISO 13485

ISO 13485 is obtained by taking ISO 9001:2000 as a base and is the management system that includes special terms for medical equipment.

This standard covers the requirements of the management system for producers working on providing medical equipment, distributors, importers and exporters, the organizations who has to prove their ability for meeting the legislation requirements applicable to the services related with medical equipment.

Medical devices quality management system ISO 13485

Medical Devices – Quality Management System (ISO 13485) benefits:

  • Provides national and international competitive advantage,
  • Increases economization, efficiency and profitability,
  • Provides product/service reliability,
  • Decreases costs,
  • Provides company acceptability by customer easily in export and internal market,
  • Provides facility for traceability.