ISO 13485

Medical Device Manufacturers – ISO 13485

The rapid development of our competence center for medical devices has continued to grow with now more than 1,200 customers certified by DQS Inc. according to the various standards of this business sector. With its excellent service, DQS Inc. continues to support customers 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.

Increasing internationalization is challenging for us and our customers but also a great opportunity. Below are the services that we already offer to our customers worldwide.

International Expertise 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.

Europe

Next to certifications to ISO 13485:2003 and the medical device directive 93/42/EEC, DQS Inc. 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. An increasing number of customers now also benefit from DQS Inc. 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.