The DITTA Medical Device Single Audit Program (MDSAP) Working Group (WG) is focusing in getting a global harmonised system for quality management audit is provided at international level.
The goal of IMDRF MDSAP is to develop an applicable program 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.
The IMDRF MDSAP WG 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.