How do manufacturers show they have been successfully audited under the MDSAP?
How do manufacturers show they have been successfully audited under the MDSAP?
Upon successful completion of an initial audit or re-audit, an AO will issue certification documents including a reference to the MDSAP that will state compliance to ISO 13485 and the applicable regulations from each jurisdiction that were used as audit criteria. Manufacturers are free to publicize their MDSAP certification in accordance with any terms and conditions imposed by their AO. However, it is not permitted to refer to products as “MDSAP certified” or “MDSAP Approved”, nor is it permitted to include the MDSAP logo or any mention of MDSAP on product labeling.