Medical device manufacturers will have to be audited according to the scope declared in their application for certification services. Based on the countries where the manufacturer sells (or intends to sell) or has devices registered, the AO will determine the regulatory requirements applicable to that manufacturer.
The AOs will have to refer to the Audit Model MDSAP AU P0002 and Audit Model Companion MDS AP AU G0002.1 to make that determination. The two documents incorporate or reference the regulatory requirements of each of the participating Regulatory Authorities.
