Clinical Evaluations & Investigations for Medical Devices

Discover industry best practice for conducting clinical investigations in light of the revision to the Medical Device Directives. Hear Mhra feedback on the latest regulatory requirements for evaluations and investigations including: class III medical devices, implantables and combination products. Gain first hand feedback, advice and updates on clinical evaluation and investigation requirements from 5 Notified Bodies. Benefit from practical insights into carrying out a clinical evaluation. Enhanced networking and experience sharing opportunities with 3 new interactive sessions.

Speaker and Presenter Information

Rob Higgins, Head of Regulatory Affairs (Devices), mhra, uk, Dr Bassil Akra, Manager - IMC / Clinical Affairs, T�V S�D Product Service GmbH, Dr Marjane Le Bagousse, Head of G-MED Certification Department, LNE/G-MED, Anwen Evans, Certification Decision Maker, medical devices, UL (UK) International Notified Body, Klaas van't Klooster, Clinical Research Manager, DePuySynthes Spine, Johnson & Johnson, emea, Dr Armin Alexander Klesius, Director Reimbursement, Health Economics & Policy Vascular Therapies Europe, Middle East & Africa (EMEA), Covidien AG, Hana Vegher, Principal Clinical Research Scientist, Abbott, USA.Fredrik Ceder, DDS Senior Manager Global Clinical Research, Global Scientific Affairs, DENTSPLY, Dr Maria Palka-Santini, Senior Clinical Research Specialist - Project Management 3M, Lisse-Lotte Hermansson, Global Director Health Economics and Reimbursement, ImmunoDiagnostics, Thermo Fisher Scientific, Eric Boulogne, Clinical Affairs and Operations, Nevro Corp, Nathalie Tretout, Clinical Research Director, TORNIER SAS, Dr Alexandra Baer, Senior Regulatory Affairs, National QPPV, Croma-Pharma, Dr Arkan Zwick, Director Regulatory Affairs and Legal, Laurie A. Clarke, partner, King & Spalding LLP, Paul Lafferty, Director and Principal Consultant, Medical Technology Consulting Limited.