Principles - Guidelines of Good Practice in Medical Devices Distribution Y.A. 1348

Medical Devices

For Medical Device Suppliers

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488(also 1996). While it remains a stand?alone document, ISO 13485 is generally harmonized with ISO 9001.

A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Download the full ISO 13485 text from here

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