Pre-assessment Audit of Technical File
By Ron Sills, M.S., Nerac Analyst
Originally Published: April 7, 2014
Introduction
The ABC Medical Company is a worldwide leader in the design, manufacture and distribution of wound care devices and wound management systems. Their product line includes moist dressings, silver-impregnated dressings, and debridement devices. 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. The company has requested Nerac perform a pre-assessment audit of the debridement devices, which are a Class IIb product family.
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. 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.
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