A continued commitment to best practices

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Fresenius Medical Care demonstrates excellence in medical devices supply chain safety

Fresenius Medical Care continues to demonstrate its ability to maintain and deliver highest standards in its medical devices supply chain ensuring meeting all safety and performance requirements while successfully completing its 1st GDPMD Surveillance Audit.

Distribution is an important activity in the integrated supply-chain of medical device. The level of risks associated with activities around the distribution may be of similar degree as those in the manufacturing environment. The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities1.

Fresenius Medical Care, THE RENAL COMPANY, was among the first companies to obtain The Good Distribution Practice for Medical Devices (GDPMD) certification granted by The Conformity Assessment Body of TÜV SÜD (Malaysia) Sdn Bhd in 2013 Certification No. GDPMD 13 12 69409 004.

GDPMD is a mandatory certification scheme that is developed to specify the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in the Medical Device Act 2012 (Act 737) (Medical Device Authority, 2013) .

As part of Fresenius Medical Care commitment to maintain its compliance with the regulatory requirements for this certification, it consistently monitors and audits its Quality Management System and Procedures to ensure the safety and performance of its medical devices in addition to conducting a full comprehensive audit every year by external auditors to ensure the conformity to the regulatory requirements.

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1 http://www.mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=35&Itemid=59