TÜV SÜD America is one of the first Auditing Organizations (AO) which, beginning July 2014, has been authorized by the International Medical Device Regulators Forum (IMDRF) to carry out audits within the MDSAP pilot program. The Medical Device Single Audit Program (MDSAP) is a project of the IMDRF. Its goal is to develop common standards for quality management audits, which will be recognized by multiple participating countries. In the future, quality management system requirements for Medical Device manufacturers according to the regulations of Canada, Australia, Brazil and the USA will be satisfied by one single audit and the approval process might be considerably expedited e.g. in Brazil. TÜV SÜD plans to carry out its first MDSAP audits in October 2014.
Read more
No comments:
Post a Comment