Auditing Organizations
This page contains information on the MDSAP Audit Approach used by recognized MDSAP Auditing Organizations (AOs) and how prospective AOs are assessed and recognized by MDSAP Regulatory Authorities (RAs).
An overview of the MDSAP Audit Approach.
Information on the MDSAP assessment process for AOs, including recognition, assessment cycles, roles, responsibilities and compliance requirements.
Information on the AO recognition process, including application requirements, assessment stages, critical location evaluations, witnessed audits, ongoing surveillance, and the appeals procedure.
The organizations listed are available to conduct audits of medical device manufacturers under the MDSAP.
Information on the MDSAP AO Contribution Scheme and resources that are available at no cost.