In Vitro Diagnostics 2017

Date: 14 – 15 June 2017

Location: Holiday Inn Kensington Forum, London, UK

Email: [email protected]

Website: www.in-vitro-diagnostics.co.uk/epr

Event Description:

The third in its series, SMi is delighted to announce the return of In Vitro Diagnostics taking place in London on the 14th & 15th June 2017. 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. Topics of discussion include: Latest updates on the IVD regulation, the changing role of notified bodies as well as the increase in requirements for clinical evidence.

Chairs for 2017:

  • Sue Spencer, Head of Global Medical Device Services, UL
  • Chris Dark, QARA Director, Arkray

Expert Speaker Line-Up Includes:

  • Alberto Gutierrez, Director, Office of In Vitro Diagnostics and Radiological Health, FDA
  • Adrian Bartlett, Medical Devices, EU Policy Manager, MHRA
  • Julien Senac, Certification Project Manager and IVD Product Assessor, LNE/GMED North America
  • Nick Baker, Technical Manager-IVD, LRQA
  • Dieter Schoenwald, Manager In Vitro Diagnostics, TÜV SÜD
  • Marta Carnielli, Manager, Safety Risk Management & Surveillance, Ortho Clinical Diagnostics
  • Alex Laan, Sr. Project Manager Medical Devices, DEKRA
  • And more…

Exclusive highlights in 2017:

  • Hear direct feedback and experiences from the FDA on In Vitro registration in USA
  • Direct your questions to our expert panel of Notified Body representatives including BSI, UL, LRQA, TUV SUD and LNE/G-MED
  • Learn how the change in classifications will impact industry with UL
  • Hear insights from Ortho Clinical Diagnostics on the increased requirements for post market surveillance
  • Examine the Medical Device Single Audit Program (MDSAP) with Berlin Heart GmbH

Early birds available!

For details or to register, visit the website at www.in-vitro-diagnostics.co.uk/epr or contact the team at +44(0) 207827 6000, email [email protected].

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