MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration (TGA) – Australia • Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil • Health Canada (HC) – Canada • Food and Drug Administration (FDA) – US • Ministry of Health and Labour and Welfare (MHLW) – Japan The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit report will be shared among all the 5 regulatory agencies and will be accepted by the FDA and substituted for routine FDA inspections. MDSAP uses ISO 13485 as the underlying standard, however it will not replace ISO certification. Canada is the only Regulatory body that will require the MDSAP Audit for licensing/registration, all other countries recommend MDSAP in lieu of their own inspection. MDSAP Companion Document The Companion Document is the most critical component of MDSAP, this outlines the audit tasks to be carried out by the auditor, linkages between the various QMS process and the country specific requirements. It is critical that the medical device manufacturer is familiar with the companion document and has addressed all requirements in the QMS. MDSAP audits are process based audits and focus on the following seven processes; 1. Management, 2. Measurement, analysis and improvement, 3. Design and development, 4. Production and service controls, 5. Purchasing, 6. Device marketing authorisation and facility registration, 7. Medical devices events and advisory notices reporting Risk Management MDSAP auditors will assess risk management activities during the audit of the QMS process. Risk management is an integral aspect of an organisation’s QMS and it is the responsibility of top management to provide the necessary commitment and resources … Continue reading Understanding MDSAP