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INTERNATIONAL ISO STANDARD 13485
https://dms.csoftintl.com/wp-content/uploads/2018/01/ISO-13485-2016-EN.pdf
WEBThis third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It …
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ISO 13485 - ISO - International Organization for Standardization
https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100377.pdf
WEBISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expec …
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ISO 13485:2016 - Medical devices — Quality management systems
https://www.iso.org/standard/59752.html
WEBAbstract. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide …
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ISO 13485:2016(en), Medical devices ? Quality management sys…
https://www.iso.org/obp/ui/
WEBThis International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more …
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ISO 13485:2016 - NQA
https://www.nqa.com/medialibraries/NQA/NQA-Media-Library/PDFs/NQA-ISO-13485-Implementation-Guide.pdf
WEBThe International Standard ISO 13485:2016 defines criteria for a Quality Management System for Medical Device Manufacturing; this ensures that all …
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