Quality Management

CPRD has a quality management system in accordance with EN ISO 13485:2003, which is a version of EN ISO 9001:2000 adapted to medical products.

Products of CPRD are developed and produced in accordance with EU Directive 93/42/EEG. They comply with the Medical Products Act and therefore carry the CE mark. This confirms that products comply with technical safety regulations and EMC guidelines for medical electrical appliances (EN60601), bio-compatibility guidelines (EN30993) and other product-specific requirements.

The development and production guidelines which have been drawn up as part of our quality management system ensure that our products are durable, highly reliable and fault-free.

We are particularly proud to have been awarded the Austrian coat of arms. The Federal Minister for Commerce and Labour awarded us the right to bear the coat of arms in 2001. This is the highest award granted in Austria and is only awarded to business that can demonstrate a high level of exports, a first-class credit rating, innovative ability, good quality management and significant investment in research and development.

To facilitate empirical data collection, a research and development laboratory with eight test places has been set up near the university in Vienna. The CPRD research laboratory is mainly concerned with norming work involving representative samples.

DIN 33430 stipulates that the norms of tests used in suitability assessment must be checked every eight years to ensure that they are still appropriate. CPRD complies with this requirement for all the tests that it sells.

quality management