If an AO issues a negative final report, can the manufacturer still sell in MDSAP jurisdictions?
If an AO issues a negative final report, can the manufacturer still sell in MDSAP jurisdictions?
MDSAP audit reports record the recommendation of audit teams for initial, continuing certification, or re-certification of the audited medical device manufacturers. When the AO determines that the audited manufacturer does not meet QMS or other regulatory requirements, each of the RAs concerned would determine appropriate actions relative to the identified nonconformities. The nonconformities may or may not be associated with regulatory requirements of all participating regulatory authorities.