Medical devices - A head start for competence The rapid development of the DQS competence center for medical devices continued in 2007. By now more than 1,200 customers have been certified by DQS according to the various standards of this business sector; and with its excellent service DQS continues to support them anywhere in the world. This growth is also a result of increasing international requirements. Therefore we will support you while entering new worldwide markets for manufacturers of medical devices. The increasing internationalization is both for us and our customers challenge and great opportunity at the same time. These are the services that we already offer to our customers worldwide: Europe Next to certifications to ISO 13485:2003 and the medical device directive 93/42/EEC, DQS also offers certifications for manufacturers of primary packaging materials for medicinal products according to ISO 15378:2006, a standard that combines the requirements of Good Manufacturing Practice with those of ISO 9001. DQS is the first German certification body to be accredited for ISO 15378:2006 by TGA (German Association for Accreditation). An increasing number of customers now also benefit from DQS assessments according to GMP Guideline 2003/94/EC, GMP Part II (GMP requirements for active substances), and the GLP Guideline 2004/9/EC. Canada Since 2003 DQS is accredited by SCC (Standard Council Canada) as official CMDCAS certification body for quality management systems. The successful re-accreditation based on ISO 17021(Requirements for bodies providing audit and certification of management systems) was carried out in 2007. USA The FDA 3rd Party Accreditation Program will continue to play a major role for our services in the U.S.. With our experts we already offer FDA pre audits to our customers and their suppliers. Russia Our customers benefit from our cooperation with DIN GOST by receiving competent support and service during the process of approving and registering their products in the Russian Federation. Taiwan, China und Japan In cooperation with our numerous partners we support our customers with the Taiwan Cover Letter, CCC (China Compulsory Certification) and the Japanese "Pharmaceutical Affairs Law”.