Servicing: meeting US and European quality system requirements

Medical device manufacturers whose products must be serviced and who wish to meet both United States (US) and European quality system requirements should pay particular attention to the servicing provisions of these requirements. The current US medical device good manufacturing practice (GMP) regulation and the new US quality system regulation contain requirements that are not included in the European quality system standards. This article will discuss the major aspects of US and European servicing requirements and some important differences.