The purpose of this transmittal is to inform MDSAP Regulatory Authorities (RAs), Auditing Organizations (AOs), Official Observers and Affiliate Members of updates to the voluntary pilot program allowing eligible Medical Device Organizations (MDOs) to participate in and apply for MDSAP certification.
Please refer to the Transmittal for details of the changes. The relevant Procedure (MDSAP AU P0038) has also been updated accordingly.