TÜV SÜD at Medica: Discussing MDSAP and Unannounced Audits with Experts

TÜV SÜD’s medical devices experts from numerous countries will be at Medica in Dusseldorf from 12 to 15 November 2014. The topics at TÜV SÜD’s stand (Hall 10, Stand C12) range from the Medical Device Single Audit Program (MDSAP) to unannounced audits at the manufacturers of medical devices and changes in the registration procedures in Japan and China.

The Medical Device Single Audit Program (MDSAP) is a project by the International Medical Device Regulators Forum (IMDRF) aimed at developing a uniform standard for quality management audits that is recognized by several participating countries. In the future, the manufacturers of medical devices will be able to prove in a single audit that their quality management systems fulfil the requirements of the regulations of Canada, Australia, Brazil and the USA, which will significantly speed up the registration process. TÜV SÜD has already started to carry out MDSAP audits and is thus able to share initial experiences.

For further information about TÜV SÜD’s services in the field of medical devices, visit www.tuev-sued.de/mhs.

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