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Different standard for sampling?

ISO 13485 & EU MDR
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Guest user Created:   Mar 06, 2019 Last commented:   Mar 06, 2019

Different standard for sampling?

ISO 13485 & EU MDR
I recently joined a medical device company that still uses the MIL standard for sampling. Is that acceptable? I am only used to ANSI at this point
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Verlene Law Mar 06, 2019

Answer:

ISO 13485 does not state any specific standard for sampling. It is the company’s responsibility to ensure compliance to relevant sampling standard according to local regulatory requirements.

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Mar 06, 2019

Mar 06, 2019

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