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Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

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.

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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Due to our rapid growth in North America, we're seeking Lead Auditors.