TÜV SÜD America is one of the first auditing organizations (certification bodies) to become authorized by the International Medical Device Regulators Forum (IMDRF) to carry out audits within the MDSAP pilot project. The Medical Device Single Audit Program (MDSAP) is designed to develop a standard for quality management audits at the manufacturers of medical devices that is mutually recognized by several countries. TÜV SÜD started to carry out audits under the MDSAP program in October 2014.
Under the Medical Device Single Audit Program, all requirements for the quality management systems of the manufacturers of medical devices according to the regulations applicable in Canada, Australia, Brazil and the USA can be assessed in a single audit in the future. This may significantly speed up the registration process for medical-device manufacturers in general as well as their registration processes in the individual countries participating in the MDSAP, such as Brazil. They can start to benefit from the offered advantages as early as the pilot phase of the program.
More information about TÜV SÜD’s services in the field of medical devices can be found on the Internet at www.tuev-sued.de/mhs.