Press release

DEKRA recognized as MDSAP auditing organization

Feb 28, 2018
International expert organization DEKRA was recognized as a Medical Device Single Audit Program (MDSAP) auditing organization. DEKRA can now help medical device manufacturers create additional confidence with international regulators through auditing and certification services.
As an independent auditing organization, DEKRA performs audits according to the MDSAP. Recently, the company was recognized by the MDSAP Regulatory Authority Council (RAC) to certify according to MDSAP as well. This allows DEKRA to offer the full range of auditing and certification services to help manufacturers meet the requirements set by market authorities.
The MDSAP was designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions, boosting efficiency and safety through increased consistency. Through certification, manufacturers are well prepared to meet the requirements of regulatory authorities in Australia, Japan, Brazil, Canada and the US.