Agenda Released for In Vitro Diagnostics 2017: Hear from FDA, MHRA and several Notified Bodies This June

22:00 EST 7 Mar 2017 |

London, United Kingdom, March 08, 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

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 For those looking to attend, there is currently a £300 discount available which expires on 31st March 2017.

In Vitro Diagnostics
14th & 15th June 2017
London, UK
Sponsored by Qarad

Contact Information:
For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email:
To register for the conference, visit or contact Adolis Miniauskas on +44 (0) 20 7827 6744 /

To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email:

About 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 create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. 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. More information can be found at

Contact Information:
SMi Group
Zoe Gale
+44 (0)20 7827 6132
Contact via Email

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Original Article: Agenda Released for In Vitro Diagnostics 2017: Hear from FDA, MHRA and several Notified Bodies This June


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