Medical Device Label Review

Medical Device entering into USA market or manufactured and sold in USA to comply with regulatory requirments as per QSR. No matter where it is manufactured or What type of device.

Important

Medical Device Label if not complying with regulations or requirements it will be considered as MISBRANDED.

"Labeling" includes all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying any such article.

A "label" is a display of written, printed or graphic matter upon the immediate container of any article.

The labeling standards accepted by the Europe are EN 980 whereas US follows FDA regulations.

I 3 Consulting can help Medical Device manufacturers and Distributors by (a) correctly identify the requirments specific to the product ( b) Prepare checklist what is missing, what to be added, what is to be edited, what graphical modification to be done etc. (C) filled checklist will be send to customer for correction and ask for corrected file. (d) Second review will be conducted and the same will be followed till all the issues get solved.

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