Donawa Maria
Donawa Consulting, Rome, Italy.
Med Device Technol. 2009 Mar-Apr;20(2):28, 30-1.
European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.
欧洲医疗器械制造商有时会惊讶地发现，仅实施ISO 13485不足以满足美国的质量体系要求。本文讨论了在单一质量体系下运营时，满足美国和欧洲要求的重要注意事项。
