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EN 46000

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EN 46000 - definition(s)

EN 46000 - Medical device quality management systems standard. EN 46000 is technically equivalent to ISO 13485:1996, an international medical device standard. The two are similar enough that if an organization is prepared to comply with one, it could easily comply with the other.

[Category=Quality ]

Source: American Society for Quality, 20 September 2010 08:19:21, External




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