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Medical Device Software & Connected Devices
Session Chair(s)
Aude Clement
Regulatory Senior Program Director
F. Hoffmann-La Roche Ltd, Switzerland
The future of healthcare lies with medicines connected with devices and digital health technologies. This session includes: - an overview of the EU regulatory landscape for Digital Health Technologies (DHT) and medical device software (MDSW). - Highlights of the key opportunities and challenges with the fast-paced evolution of connected medical devices and MDSW based on diabetes care use cases. - lessons learnt on satisfying the needs of patients, HCPs, and regulators when adding electronics to drug delivery devices - perspectives from an EU notified body on smart and connected medical devices
Learning Objective : 1) Understand the current global regulatory landscape for digital health technologies 2) Compare and contrast how MDR and IVDR implementation, including Rule 11, impacts utilization of DHTs in clinical trials and patient care 3) Identify key considerations and challenges regarding use of DHTs in clinical trials, including partnering with third party software vendors
Speaker(s)
Searching for an Identity: EU Regulatory Landscape for DHT and Software
Aude Clement
F. Hoffmann-La Roche Ltd, Switzerland
Regulatory Senior Program Director
Fast-Paced Evolution of Connected Medical Devices and Software: Regulatory and Patient's View on Challenges and Opportunities
Laura On Behalf of EFPIA European Regulatory A Pastor Sanz, PhD, MSc
Novo Nordisk, Denmark
Digital Health Policy Lead
Adding Electronics to Drug Delivery Devices: Satisfying the Needs of Patients, Healthcare Professionals and Regulators
Yury Rozenman
Ada Health, United States
Senior Vice President, Pharmaceutical and Life Sciences
Smart and Connected Devices: Perspectives from an EU Notified Body
Sebastian Fischer
TÜV SÜD Product Service GmbH, Germany
Regulatory Strategy Principal
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