Quality Management

Pi Medical established a quality management system for the design and manufacturing of medical software products, as well as for trading and service of medical devices for oncology.

This system fullfil the ISO 9001:2008 and ISO 13485:2012 standards and is certified by TUV Austria Hellas since 2003 (initially for ISO 9001:2000 and later for 9001:2008). 

The developmed of software products or parts of products is also following the EU Directive 93/42 while the products launched in the world market are CE marked and FDA certified. Furthermore, specific quality standards for medical devices (e.g. CEI/IEC 601-1-4, CEI/IEC 62083) are followed according to the needs of our customers.

ISO 9001:2008 Certificate611.36 KB
ISO 13485:2012 Certificate2.45 MB