KHERA CONSULTANTS LIMITED

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.