ISO 13485:2003: Medical devices - Quality management systems - Requirements for regulatory purposes
- Medical Devices
This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. It can also be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer and regulatory requirements.
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