This paper reviews the quality system options within the Medical Devices Directive 93/42/EEC (MDD) and their applicability to manufacturers of electromedical equipment, accessories and software. This includes the relationship with the ISO 9000 and EN 46000 quality system standards. Finally, the authors describe the role of the Notified Body in certifying quality systems and how conformance with the Essential Requirements of the MDD are demonstrated in the absence of an EC Type Examination. The paper is based on the world wide experience of SGS, the world's largest inspection, testing and certification organisation, and in particular SGS Yarsley ICS, the UK based UKAS accredited certification body and Notified Body 0120.
展开▼
机译：本文回顾了医疗器械指令93/42 / EEC（MDD）中的质量体系选择及其对电子医疗设备，配件和软件制造商的适用性。这包括与ISO 9000和EN 46000质量体系标准的关系。最后，作者描述了认证机构在认证质量体系中的作用，以及在没有进行EC型式检验的情况下如何证明符合MDD的基本要求。本文基于全球最大的检验，测试和认证组织SGS的全球经验，特别是基于SGS Yarsley ICS，英国UKAS认可的认证机构和Notified Body 0120。
展开▼
