Software intended for clinical use, under the Medical Device Regulations (or their local equivalents), may be classified as a Medical Device, and subject to the relevant requirements and constraints. The group producing the software are classed as “the manufacturer”. Using the software clinically in-house (“putting it into service”) requires demonstrating a certain level of manufacturer quality control. Giving or selling the software to another hospital (“putting it on the market”) requires that it be CE or UKCA marked. CE/UKCA marking is not a defence against harm caused to patients through use of the software; rather, it is one sign of the manufacturer’s due diligence.
The purpose of these two webinars is to highlight and draw out strategies through this complexity, within the context of the health system, academia and patient communities.
Session 1 “Why”. Wednesday, 20th January, 2020, 5:00 p.m. GMT for one hour.
Dr Matt Guy Head of Imaging Physics, University Hospital SouthamptonMatt leads a team of scientists delivering diagnostic digital health solutions. He established and leads a Scientific Computing team at Southampton to ensure in-house development meets both regulatory requirements and patient needs. He is a vocal patient advocate, highlighting gaps left by med tech and academia, and contributing to community software solutions.
Haroon Chughthai Research Software Developer, UCL and Honorary Senior Researcher, UCLHHaroon is a Research Software Engineer at UCL jointly in the Research Software Development Group and the Centre for Medical Image Computing, as well as working closely with UCLH BRC's Clinical and Research Informatics Unit. His work involves deployment of imaging data management infrastructure and the development of sustainable software to support and enable research. Prior to this Haroon undertook the NHS Scientist Training Programme, whilst based at UCLH, gaining registration as a Clinical Scientist.
Session 2: “How” Wednesday the 27th of January, at 5:00 p.m.
Dr James Leighs, Senior Clinical Scientist & Software Engineer, University Hospital SouthamptonDr Leighs has experience in a variety of fields involving the application of computer science to Physics and Biology. Within the NHS, he has worked on and led projects in areas such as Nuclear Medicine, MRI Physics, Paediatric Intensive Care, Radiotherapy, Radiation Protection and Molecular Genetics, many of which have produced Medical Device software. He has also led the design and implementation of a Quality System for the development of medical device software at UHS.
Marco Rizzardo, Software Group Leader, Medical Technologies Division, Cambridge Consultants Marco is a Software and Systems Architect with over 15 years of experience within the healthcare industry. He has led the software component and participated in the development of the overall System Architecture of some largest and most complex software projects Cambridge Consultants has developed
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