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Common QMS Mistakes SaMD Companies Make

Global Medical Device Podcast powered by Greenlight Guru

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Is Your Quality Management System a Software or a Physical?

In your quality manual, have your non-applicable state of it and put a justification. It just makes the auditors life a lot easier. What are you going to do when the R-A manager is not available? So what I always say to companies is always in your procedures stay that at certain times or in certain cases that you may give this to a suitably trained deputy.

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