Aimed at Managers/Heads and Directors of Regulatory Affairs, In-Vitro Diagnostics, Clinical Affairs and Quality Assurance, IVDs 2017 will provide regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape.
Through a series of presentations from handpicked industry experts and Notified Bodies, the 2017 event will prepare attendees for the challenging times ahead and how to comply with regulatory requirements to ensure direct access to market ensuring the continued growing demand for use and innovation of IVDs over the next decade and beyond.
In line with this, SMi has announced that the MHRA & the FDA will both be presenting key discussions about In Vitro Diagnostics regulations within the EU & USA.
On day one Adrian Bartlett, Medical Devices and EU Policy Manager from MHRA will provide attendees with his presentation on 'A closer look at the new EU regulations on in vitro diagnostic (IVD) devices'. He will highlight the main changes occurring as well as discuss the key challenges from a competent authority perspective and discuss how to comply with timelines.
Alberto Gutierrez, Deputy Director of IVD, Office of In Vitro Diagnostic Device Evaluation and Safety from FDA will be presenting on day two of the conference on 'In Vitro Diagnostic Regulation in USA'. Alberto will explore: In-vitro diagnostic classification, pre-market and post-market requirements in USA, product life cycle: modifications and new product development and prescription vs over the counter requirements.
MHRA and FDA will be joined by LNE/GMED North America, LRQA, TÜV SÜD, Ortho Clinical Diagnostics, DEKRA and more…
A full roster of speakers and their presentations can be found at www.in-vitro-diagnostics.co.uk/1888