I believe I understand what this requirement is saying, but could someone please confirm whether my grasp of this "shall" is correct?
The shall: "...The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.."
My understanding of it: In our company, we have many distributors who sell our product to end users who could be located anywhere in the world. According to this "shall", we must require our distributors to maintain records of some kind that would allow us to trace our product to the end user, and we should be able to inspect those records.
Please correct me if this is not the correct interpretation of this "shall"....
Thanks so much for your help!
The shall: "...The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection.."
My understanding of it: In our company, we have many distributors who sell our product to end users who could be located anywhere in the world. According to this "shall", we must require our distributors to maintain records of some kind that would allow us to trace our product to the end user, and we should be able to inspect those records.
Please correct me if this is not the correct interpretation of this "shall"....
Thanks so much for your help!