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An AO is an organization that audits a medical device manufacturer for conformity with Quality Management System (QMS) requirements and other medical device regulatory requirements.
MDSAP uses third-party AOs that have undergone an assessment by a Regulatory Authority (RA) to be recognized. For a list of recognized MDSAP AOs available to undertake MDSAP audits, please click here.
Information on how to become a recognized MDSAP AO is available at AO Assessment Process.