Sampling method for Distributor verification activities

#1
Hi all,

MDR says that distributors can apply a sampling method in order to check some points of compliance of the device they supply. Does anyone know a standard or a procedure suggesting a sampling method that we can use for meeting this requirement, please ?

Many thanks.
 
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#2
Hi all,

MDR says that distributors can apply a sampling method in order to check some points of compliance of the device they supply. Does anyone know a standard or a procedure suggesting a sampling method that we can use for meeting this requirement, please ?

Many thanks.
Good day Quaffreg, welcome to The Cove! I am sorry for the delay in this response.

I think that ANSI/ASQ Z1.4 is the most recognized specification for sampling plans. It supersedes the long-referenced MIL-Std-105E and is available for purchase from ASQ and other sources.

I found the article titled An Introduction to Sampling Plans on Pharmaceutical Online. I hope it is helpful.

Disclaimer: I am not affiliated with Pharmaceutical Online, but I am an ASQ member.
 
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