Donawa Maria
Donawa Consulting, Rome, Italy.
Med Device Technol. 2009 May-Jun;20(3):24-7.
Medical device manufacturers operating under European quality system requirements are sometimes surprised to learn that their supplier control procedures do not fully meet United States (US) requirements. This article discusses important differences between US and European requirements for controlling suppliers.
按照欧洲质量体系要求运营的医疗设备制造商有时会惊讶地发现,他们的供应商控制程序并不完全符合美国的要求。本文讨论了美国和欧洲在供应商控制要求方面的重要差异。