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Medical device single audit program (MDSAP)
Working Group Chair(s)
Food and Drug Administration (FDA)
United States of America
kimberly.trautman [at] fda.hhs.gov
The Medical Device Single Audit Program (MDSAP) Work Group has completed its work and has moved to the implementation phase. For current information on implementation see MDSAP
The Working Group will develop a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers' quality management systems. The document will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. This is an initial critical step in establishing a single audit program. This action will complement the current ISO13485 revision process under which IMDRF seeks modifications to achieve a harmonized standard amongst its members.