Medical device

Compatibility of procedures with the medical norm ISO 13485 in purchasing and manufacturing.

DGTronik is dedicated manufacturer of a medical device for one of our customers. A succesful audit of procedures, processes and ways of proceeding to check compatibility with the relevant parts of the medical norm ISO 13485 has been accomplished by TUV Reinland. The standards of ISO9001:2008 have been improved with deeper treacibility of used components on every stage of the manufacturing process as well as securing of components certificates and detailed records of all manufacturing  processes.