Lally R
Amtac Certification Services, Altrincham, UK.
Med Device Technol. 1996 Sep;7(7):28-33.
This article outlines key issues that will aid successful compliance with the requirements of the Medical Device Directive through ISO 9000/EN 46000. A well-constructed quality system that complies with these standards will also act as a good basis for ensuring compliance with many other global regulatory requirements.
本文概述了一些关键问题，这些问题将有助于通过ISO 9000/EN 46000标准成功符合《医疗器械指令》的要求。一个构建良好且符合这些标准的质量体系，也将成为确保符合许多其他全球监管要求的良好基础。
