Especially with regard to medical devices quality and particularly quality assurance are of crucial importance as they affect human health.
Right from the start, we have established a transparent quality management. In this way, we ensure that all requirements regarding a certified company pertaining to the choice of raw materials, product development, manufacturing, sterilization, quality assurance, storage, sales, and client service are 100 per cent fulfilled. Part of our comprehensive quality management is, for example, that we produce the blister packaging for our products in-house under clean-room conditions.
In 1995 we, as one of the first breast implant manufacturers worldwide, had introduced the CE mark for our products. At this early stage we voluntarily implemented the quality standards as applicable for class-III products, mandatory for all breast implants since 2004.
In 2003, a medical device directive had been adopted in Europe according to which breast implants have since been classified as class-III medical devices. As of 1 March 2004 all breast implants used in the European Community have to comply with the highest safety requirements. Our products had received the respective approval as early as December 2003 – for us a sign of acknowledgement of the quality standards we had established many years ahead.
For us, it is a matter of course to adhere to quality standards. We continually adapt all processes to the current legal requirements and constantly improve the quality of our products. This is how we have been able to satisfy and even exceed the growing demands of the market for more than 25 years.
We guarantee quality made in Germany.