The certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market.
If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.
LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.
Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe.
Topic: Initial Certification Audit – Common Pitfalls for Medical Device Manufacturers
Date: Wednesday, February 22nd, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time
Presenter: Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.