Giorgio Sorcini provides regulatory consulting services to Medical Devices manufacturers, supporting products design, development and industrialization in compliance with requirements of European directives (CE mark) and national legislation. He graduated in Aeronautical Engineering in 1988 at “La Sapienza” University of Rome. After a first experience in aeronautical industry (advance composites materials / R&D management), he was involved (Tecnobiomedica SpA, Rome) in Medical Devices development, cooperating in the Artificial Heart project with design, processes development, biocompatibility testing, validation on bench and animal model activities management. In 2002 he joined CUBE Srl (Bergamo) as Director for Research & Development of an innovative heart function mechanical support device, coordinating design, development, prototypes production, long term fatigue testing and animal model validation in different European centers (Brescia, Leuven, Paris). From 2006 he acts as a free-lance consultant in regulatory and Quality Assurance fields mainly supporting innovative devices firms in interventional and cardiac fields.
Expertise:
- Medical Devices CE marking activities
- Technical File
- Clinical Evaluation of Medical Devices
- Medical Devices Risk Management
- Industrial design and processes validation
- Quality Systems
- Planning and Management of Clinical trials