![]() ![]() The outcomes of this audit and any corrective or preventive actions implemented will help to prepare the company for an audit of the technical file and QMS by their notified body. ![]() ![]() The goal of the Nerac audit is to assess compliance with the essential requirements of the MDD and with the company’s quality management system (QMS) certification per EN ISO 13485:2012. All European CE marking directives oblige the manufacturer to draw up a Technical File (or in the directives youll also find. In addition many planing craft are required to meet the sound and exhaust emission standards. All the other contents of the Technical Documentation are the same for both the marking systems. Prior to 1st January, 2006 RCD Compliance could be self- declared as a Design Category C craft, however from 1st January, 2006 all imported craft from outside of the EEA using Post-Construction assessment have to engage a Notified Body. Therefore, the Technical Documentation and Declaration of Conformity for the UKCA mark would use the British national BS pre-fix, for example BS EN ISO 13857. The company has requested Nerac perform a pre-assessment audit of the debridement devices, which are a Class IIb product family. For the UKCA UK Designated Standards should be referred which are the British Standards. The products are assembled into technical files as product families, based on their classification per the Medical Devices Directive 93/42/EEC 2007, Annex IX. Their product line includes moist dressings, silver-impregnated dressings, and debridement devices. The ABC Medical Company is a worldwide leader in the design, manufacture and distribution of wound care devices and wound management systems. ![]()
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