QSR May Eventually Direct Firms To Gather, Use Customer Feedback

摘要

FDA may bring the Quality System Regulation more in line with ISO 13485 regarding the idea that medical device manufacturers should use customer feedback to enhance their quality systems and keep customers satisfied, an agency official says. "One difference between the Quality System Regulation and ISO 13485 is the idea of continuous improvement and customer satisfaction," Tim Ulatowski, director of CDRH's Office of Compliance, told "The Silver Sheet." "It's not an element of our regulation, but certainly from a business perspective it's important." ISO 13485 is the international quality system standard for medical aevice manufacturing used in the European Union, Canada and Australia, among others. Its requirements for device manufacturers are similar - but not identical to - the QSR.