Audits FAQs
Responses to commonly asked questions related to MDSAP Audits.
Information on how to contact an MDSAP AO.
Information on the MDSAP Audit Approach requirements.
Information on the MDSAP’s coverage of medical device regulations.
Information on the MDSAP’s Audit Approach process.
Information to be provided medical device manufacturers during the audit process.
Information on how audit time and the number of auditors required is determined.
Information on how auditors are assigned.
Information on jurisdictions where manufacturers need to be compliant with regulations.
Information on MDSAP and RA audit mechanisms, including special audits.
Information on RA action when a manufacturer has not met QMS or other regulatory requirements.
Information on issue of MDSAP certification documents.
Information on MDSAP participation for manufacturers under regulatory action.
Information on contracting with another MDSAP AO and MDSAP RA considerations.
Information on how non-participating RAs can access MDSAP audit reports and verify MDSAP certificates.
Information on European requirements and MDSAP Audit Approach.
The definition of a “campus” under the MDSAP.
Information on main benefit of the “campus” concept.
Information on audit tasks undertaken during multi-site audits.
Information on application of the MDSAP Audit Approach to dispersed site responsibilities.
Information on sites able to be recorded on the MDSAP certificates.
Information on audits of “virtual” manufacturers.
Information on application of the MDSAP Audit Approach to dispersed site responsibilities.
Information on MDSAP AO engagement of technical expert.
Information on when an RA inspection may be required.’
Information on the requirement for an initial response period.
Information on transfer guidelines and other resources
Information on the period to reference a jurisdiction where no product is distributed.
Information on the exclusion of a jurisdiction or products from the MDSAP audit scope.
Definitions for counterfeit medical device and fraudulent activity requiring RA notification.
Information on the activities/processes, products or facilities that are eligible for exclusion from the MDSAP.