In order to fulfill our commitment to quality, we incorporated the new FDA Quality System Requirements (CGMP, CFR 21) and the international Quality Standards (ISO 14971 and ISO 13485) in all areas of our facility, including the repair, rebuild and replacement departments. Please see our Quality Page to view Certificates. While it is not necessary, by law, to incorporate these standards in the repair/rebuild department, we felt compelled to establish one level of quality control throughout the facility, thereby guaranteeing the highest standards for all of our services. This decision resulted in a significant increase in our quality level and has been a major factor in raising the confidence of our customers.