US Endoscopy's quality management system meets the requirements of the applicable worldwide Quality System standards, including ISO 13485, 21 CFR Part 820 Quality System Regulations, Medical Device Directive 93/42/EEC, Health Canada's CMDCAS (Canadian Medical Device Conformity Assessment System), and Japan's Pharmaceutical Affairs Law Ministerial Ordinance 169. The quality system at US Endoscopy is third-party certified to the applicable standards, and we are authorized to affix the CE mark on our products for marketing and distribution in the European Union.
Our quality systems registrar and notified body is BSI, a prominent Notified Body recognized throughout
ISO 13485 Registration
STERIS Corporation: Quality System Certificates