The MDSAP (Medical Device Single Audit Program) is a program that allows the performance of a UNIQUE AUDIT of the quality management system of a manufacturer of medical devices and IVDs in order to be able to demonstrate the satisfaction of the requirements for the quality system foreseen by the Regulatory Authorities of the countries participating in the program (USA, CANADA, JAPAN, AUSTRALIA, BRAZIL).
Maytal is able to support manufacturers of medical devices and IVDs, who intend to export to the countries participating in the MDSAP:
  • to implement the Quality System in compliance with the MDSAP requirements;
  • perform internal audits, audits to outsourced suppliers evaluated as critical;
  • assist the company during the certification audit