Medical devices – Quality management systems – Requirements for regulatory purposes

ISO 13485 specifies requirements for a quality management system that can be used by an organisation involved in one or more stages of the life-cycle of a medical device.

These include design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development or provision of associated activities.

The Standard can also be used by suppliers or external parties providing products such as raw materials, components, subassemblies, medical devices, sterilization, calibration, distribution, and maintenance services.

For a quote or more information, don’t hesitate to contact us.

 QMS ISO 9001 for Medical Devices ISO 13485 certification

Call the ISO Certification experts on +61 8 8347 0603

ISO 9001, ISO 14001, ISO 45001, FSSC 22000, ISO 22000, HACCP, ISO 27001, ISO 55001 and more