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Hello All,
I have a question in regard to ISO 13485 7.5.1.2.1 Cleanliness and Contamination of Product.
I currently manufacture a product that I sell through distribution. I do not clean the product prior to or after processing. My customers does not have to clean the product prior to use; however, the end user does and this is addressed in the Directions for use (DFU), developed by the distributor.
In regard to ISO 13485 7.5.1.2.1 do I have to develop a procedure that defines the cleaning of the product prior to use, as it is detailed in the DFU or can I make the DFU a controlled document and use the DFU to satisfy the above standard?
Thanks
I have a question in regard to ISO 13485 7.5.1.2.1 Cleanliness and Contamination of Product.
I currently manufacture a product that I sell through distribution. I do not clean the product prior to or after processing. My customers does not have to clean the product prior to use; however, the end user does and this is addressed in the Directions for use (DFU), developed by the distributor.
In regard to ISO 13485 7.5.1.2.1 do I have to develop a procedure that defines the cleaning of the product prior to use, as it is detailed in the DFU or can I make the DFU a controlled document and use the DFU to satisfy the above standard?
Thanks