Q
Curious as to how other Quality Managers maintain their Device History Records when customers state that they have discontinued the use of the product. Is there anyone willing to share briefly their process? I'm thinking that a letter to file or copy of the email from the customer stating that their device has been dispositioned for whatever reason as proof of evidence that the unit retired or at least will let someone know in the future that it has been discontinued.
Is there a formal way of handling it? Looking at the FDA 21 CFR 820.184, there is specific requirement other than it is the company's responsibility to maintain. Any opinions?
Thank you!
Is there a formal way of handling it? Looking at the FDA 21 CFR 820.184, there is specific requirement other than it is the company's responsibility to maintain. Any opinions?
Thank you!