Agenda Released for In Vitro Diagnostics 2017: Hear from FDA, MHRA and several Notified Bodies This June
Summary
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 Featured Speakers: • 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… Event highlights will include: • 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 A full speaker line-up and detailed conference agenda is available to download online at www.in-vitro-diagnostics.co.uk/prcom For those looking to attend, there is currently a £300 discount available which expires on 31st March 2017.We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network.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, ArkrayFeatured Speakers:• 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…Event highlights will include:• 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 GmbHA full speaker line-up and detailed conference agenda is available to download online at www.in-vitro-diagnostics.co.uk/prcom For those looking to attend, there is currently a £300 discount available which expires on 31st March 2017.In Vitro Diagnostics14th & 15th June 2017London, UKSponsored by Qaradwww.in-vitro-diagnostics.co.uk/prcomContact Information:For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale@smi-online.co.ukTo register for the conference, visit www.in-vitro-diagnostics.co.uk/prcom or contact Adolis Miniauskas on +44 (0) 20 7827 6744 / aminiauskas@smi-online.co.ukTo sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities.We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network.