Medical Device Compliance and Quality Management System (QMS)
Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch. As with the US FDA’s Quality System Regulation – QSR; and with Europe’s ISO 13485, manufacturers should adhere to the regional quality system regulations for compliance.