Moderator: Silvia Tamarri – General Director Thema

Speakers:
Stefano Severi – Associate Professor of Department of Electrical, Electronic, and Information engineering “Guglielmo Marconi” – DEI University of Bologna – “Design and innovation in the current technological context”
Massimiliano Testi – Medical Device Department Manager, TÜV Rheinland Italia – “Critical issues and opportunities in the development of innovative medical devices”
Gail Rodriguez – Senior Policy Advisor/Food & Drug Administration [promoted by RAPS ITALY Local Networking Group] – “Upping Your Conformity Assessment Game: Putting Standards to Work to Streamline Device Review”
Denis Dmitrenko – MedSec Testing, Australia – “Delivering a cyber-secure medical device”
Mario Federighi – CEO & Chairman Farmigea / Special Advisor in Confindustria, Confindustria Medical Devices Regulatory Affairs – “Mood and reality: feedback from the medical industry”

Moderator: Caterina Montesi – Operations Manager Thema

Speakers:
Mario Gabrielli Cossellu – Principal Administrator Legal and Policy Officer Medical Devices – European Commission Directorate – General for Health and Food Safety – “The evolution of medical compliance in the European system”
Alessandra Basilisco -Office III – Medical Devices and active implantable medical devices of the Italian Ministry of Health – “The regulatory impact on marketing medical devices: data analysis and considerations”
Carlos Pérez Barrionuevo – Regulatory Affairs (IVDR & MDR) Manager Medical Devices – MedTech Europe – “The aspects of the device lifecycle that really matter to the medical industry”
Francesca Gritti – Certification Specialist, IMQ Istituto Italiano del Marchio di Qualità – “Obtaining and maintaining MDR certification: step by step”
Roberta Marcoaldi – National Institute of Health (ISS) Director (Notified Body 0373) – “Planning as a key element in the pre-clinical phase”

Moderator: Silvia Tamarri – General Director Thema

Speakers:
Diego Falletti – Technical Team Manager, Regulatory Services – Vascular Devices BSI Group Italia – “State of the art: how to demonstrate post-market compliance”
Alessia Frabetti – Medical device Business Unit Director, KIWA Cermet Italia – “Use of retrospective studies of already-marketed devices”
Germana Paulillo – Italy & France Team Lead, DNV – “Product change management in the post-certification phase”