Pre-assessment Audit of Technical File
By Ron Sills, M.S., Nerac Analyst
Originally Published: April 7, 2014
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.
Learn more here.
Get Our Free Article
Simply fill in the form below, verify your email address
and you’ll be sent a link to download our free article.
- 74By Ron Sills, M.S., Nerac Analyst, Originally Published: October 3rd, 2014 Is your company ready for an audit by your notified body? Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that…
- 72By Ron Sills, M.S., Nerac Analyst Originally Published: June 22nd, 2015 Nerac was approached by several medical device manufacturers after receiving formal citations by their notified bodies for non-conformities in their clinical evaluation reports, specifically pertaining to the state-of-the-art analysis for their products. This state-of-the-art requirement is specified in the MEDDEV 2.7.1 Rev. 3 document,…
- 65Did you miss our recent webcast "Updating Technical Files - Is Your Company Ready for a Notified Body Audit?" Listen to it here!