Dave has been the Global Technical Steward for Combination Products and Medical Devices since October 2013. In this role, Dave oversees all global operational and maintenance activities related to Medical Devices & Combination Products at Novartis globally and his team supports multiple development programs and projects containing medical devices and or combination products.
He is also the operational representative for the Medical Device and Combination Product Expert Network at Novartis, as well as member of several other cross-functional boards.
Dave joined Novartis in 2009, through the acquisition of Nektar Therapeutics and has contributed to the industrialization and commercialization of several programs in that time.
He has over 25 years of experience in R&D, and Manufacturing within the Consumer electronics, Medical Devices & Pharmaceutical Industry.
Before joining Novartis, he held several roles in fortune 100 companies including West Pharmaceuticals, Apple and General Electric focusing on the development and commercialization of pharmaceutical delivery systems and consumer electronics.
He studied Engineering and holds both a Bachelors and Masters of Science in Plastics Engineering, from the University of Massachusetts, USA. He is aslo a gradute of the General Electric Chemicals and Materials Leadership program and is a certified Six Sigma Black Belt.
This workshop will provide an overview of the journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR. The presentation will be focused in two parts – firstly an overview of the adaptation of the quality system to incorporate and address the elements required under the MDR followed by a discussion and reflection of the challenges and strategies used to successful upgrade and certify an inhaler device platform supporting both commercial and development products.