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I work for a small medical device manufacturer. FDA regulations call for inspection and test equipment to be capable of producing valid results.
What is the common practice in the industry to meet this requirement?
Does it require a full blown MSA involving dozens of inspection tools and
many operators or a simple Gage R & R study with a few of the most commonly used tools and inspectors only? If you are in the medical device industry, please let me know how you are meeting this reqirement.
Thanks
What is the common practice in the industry to meet this requirement?
Does it require a full blown MSA involving dozens of inspection tools and
many operators or a simple Gage R & R study with a few of the most commonly used tools and inspectors only? If you are in the medical device industry, please let me know how you are meeting this reqirement.
Thanks