We have been continuously improving our quality assurance system, which is certified by SGS, since 1997. This system was renewed in 2003 and it is audited each year according to the requirements of ISO9001 and ISO13485 standards, which ensures a constant high quality in the development, manufacturing and customer related processes. All of our products comply with the EU Medical Devices Directive, they bear the CE mark and they satisfy the requirements of other safety and performance standards as well. Our ABPM-04 and ABPM-05 ambulatory blood pressure monitors have FDA approval, which ensures their distribution in the United States. Moreover, our quality system has been modified to fulfill the requirements of the Medical Device Regulation of Canada as well.