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ISO 13485:2003: Medical devices - Quality management systems - Requirements for regulatory purposes
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ISO 13485:2003: Medical devices - Quality management systems - Requirements for regulatory purposes

PDF, 64 pages, Published 2003
Item Number: T13485E

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Keywords

  • Medical Devices
  • Standards

Description

This is now a historical document. It has been replaced by ISO 13485:2016. This historical document may be helpful when making the transition to the updated standard.

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.

A technical corrigendum was issued for this standard after its publication. To request this FREE document, please email us.