Medical device manufacturers must establish their quality systems in compliance with the appropriate regulations and standards. Failure to do so can result in poor product quality, loss of certification or lack of process improvement. Our services assist Medical device companies to establish, update, and maintain Quality Management System including GMP (Good Manufacturing Practice) in compliance with the local regulation, FDA Quality System Regulation (FDA QSR), European Device Directives, ISO 13485, and Canadian Medical Device Regulations (CMDR).