I have been contacted by an organisation in the UK that buys in and distributes medical equipment from abroad. The manufacturers have ISO 13485 certification and the distributor has certification to ISO 9001 - albeit non-UKAS accredited.
They have tendered for a large contract and been told that they must also be certificated to ISO 13485.
My knowledge does not stretch to medical devices but I was under the impression that it was a manufacturing standard and as such, not necessary for a distributor. Can anyone help me on this please?
They have tendered for a large contract and been told that they must also be certificated to ISO 13485.
My knowledge does not stretch to medical devices but I was under the impression that it was a manufacturing standard and as such, not necessary for a distributor. Can anyone help me on this please?