In order to achieve and maintain a position of sales and quality leadership in the medical device industry, Lake Region Medical designs, develops, and manufactures products that meet or exceed customer requirements.

Lake Region Medical complies with the current U.S. FDA Quality System Regulation (QSR), uses international standard ISO 13485 as a model for establishing internal quality systems, and complies with the pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169.

quality Nearly 50 years medical device experience FDA, QSR, ISO 13485 Japanese PMDA compliant for device design & manufacturing

full regulatorY capabilities 510(k) Design History File compilation Device History File management CE Mark Technical dossiers PMA support Clinical complaint management and analysis Established design control process