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Initial Audits – Common Pitfalls

Join us on Wednesday, February 22nd at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the Initial Audits – Common Pitfalls.

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The certification audit is a major step for a Medical Device manufacturer to access the market.

In this webinar, we will go through several common pitfalls that could delay Company’s time to market.

With a broad experience in ISO 13485, CE marking and ISO 13485 within CMDCAS audits, we have surveyed our auditors to identify the main topics that lead to major non-conformities and that could therefore impact the certification timeframe.

From gaps in the Quality System definition to incomplete Device Technical Documentation, the webinar will highlight the mains topics for which major non-conformities are raised during initial audits.

Join LNE/G-MED and our Director of Regulatory, Education and Quality, Florianne Torset-Bonfillou to hear about the critical non-conformities that can slow down access to market, from the quality scope definition to the completion of the device documentation. You can tune to LNE/G-MED North America’s upcoming free webinar on the Initial Audits – Common Pitfalls.


Florianne Torset Bonfillou LNE Gmed

Topic: Initial audits – Common Pitfalls
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. 
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