Hi - once again I am in need of some "experienced and seasoned" help.
I am struggling with some folks trying to explain that I feel our use of the following will only create problems and I don't know how, in the best words to convey that..........
Currently, the company has one IFU for a Class IIb product (Rx Only Device) tht is ENGLISH text only. They send this IFU to the USA only.
They have another IFU for the same Class IIb product (Rx Only Device) that contains ENGLISH and all other languages.
What I have found is that the english text has differences betweeen the manuals. My concern is that the translated language MUST be exact to the English.
Is it common practice to have 2 versions of English IFUs for the same product?
Kind regards and thank you in advance for any help/suggestions/ideas....

I am struggling with some folks trying to explain that I feel our use of the following will only create problems and I don't know how, in the best words to convey that..........
Currently, the company has one IFU for a Class IIb product (Rx Only Device) tht is ENGLISH text only. They send this IFU to the USA only.
They have another IFU for the same Class IIb product (Rx Only Device) that contains ENGLISH and all other languages.
What I have found is that the english text has differences betweeen the manuals. My concern is that the translated language MUST be exact to the English.
Is it common practice to have 2 versions of English IFUs for the same product?
Kind regards and thank you in advance for any help/suggestions/ideas....

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