Join us on Wednesday, September 27th, 2017, 2:00 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on IVD European Regulation: how QMS requirements interacts with ISO 13485:2016.
Medical Device Manufacturers went through significant changes in the last couple of years: The publication of ISO 13485:2016 on February 25th, 2016 introduced a new level of expectations in regard to their QMS compliance.
For In Vitro Medical Device Manufacturers, an evaluation of their processes and their overall QMS with regard to ISO 13485:2016 is essential: through a gap analysis and the design of an action plan, In Vitro Medical Device Manufacturers have started to establish the foundation to successfully transition to ISO 13485: 2016. However, with the publication on May 25th, 2017 of the new EU In Vitro Diagnostic (IVD) Regulation, a reassessment of this plan is needed to integrate the specific QMS requirements linked to this new regulation...
Topic: IVD European Regulation: how QMS requirements interacts with ISO 13485:2016
About the presenter: Dr. Julien Sénac is an IVD specialist, Certification Project Manager and Technical Documentation Assessor for LNE/G-MED North America, Inc.
Date: Wednesday, September 27th, 2017
Time: 2:00 pm Eastern Time