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.
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