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... Click here to READ MORE!
UPCOMING TRAINING: Transition to ISO 13485:2016
Only a few Tickets Left!
Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard.
Pick one date: February 14th or 15th 2017.
About the presenter: Florianne Torset-Bonfillou
Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.