Research - Leeds, England, United Kingdom
Over twenty-five years of research and development experience that has involved managing development teams, architecting, designing, and implementing Medical Devices and Systems (including Digital Health and Software as a Medical Device (SaMD)).Comprehensive knowledge of complete lifecycle for product development from concept to mass production.Regulatory Standards:IEC 82304, IEC 62304, ISO 14971, IEC 62366, IEC/TR 80002-1:2009, IEC 60730, AAMI TIR57, UL 2900-1, UL 2900-2-1, IEEE Standard Part 40101, IEEE Standard Part 40102, MDCG 2019-11, IMDRF - "Software as a Medical Device", MHRA guidance document "Medical device stand-alone software including apps"Research in Image Recognition, Digital Signal Processing, Computer Graphics and Neural Networks (NN). Deep Learning is a subset of NN and generally refers to an implementation which has more than 3 layers in the NN. So called Machine Learning (ML) is a superset of NN and in turn is a subset of Artificial Intelligence (AI).EXPERT IN:• Medical Devices and Systems Development (including software and hardware) from concept through to Regulatory Submission and approval.• Risk Analysis and Management of Medical Devices and Systems.• Management of Cybersecurity in Medical Devices and Systems.• Managing, Leading and Mentoring Engineers.A good communicator, both verbally and written and a quick learner willing to learn new skills and to share knowledge with others.