Dr. Bulla Singh's Linkedin Analytics

With over 25 years of experience in research and development, I have successfully led development teams while contributing to the architecture, design, and implementation of Medical Devices and Systems, including Digital Health and Software as a Medical Device (SaMD). Throughout my career, I have gained comprehensive knowledge of the entire product development lifecycle, from initial concept to mass production. I am well-versed in various regulatory standards, such as IEC 82304, IEC 62304, ISO 14971, IEC 62366, IEC/TR 80002-1:2009, IEC 60730, AAMI TIR45, ANSI/AAMI SW96, AAMI TIR57, AAMI TIR97, UL 2900-1, UL 2900-2-1, AAMI/UL 2800-1, AAMI/UL 2800-1-1, AAMI/UL 2800-1-2, AAMI/UL 2800-1-3, IEC 81001-5-1, 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", ETSI EN 303 645, and ISO/IEC 27001. I have honed my expertise in the following areas: - Full-cycle development of Medical Devices and Systems, including software and hardware, from ideation to Regulatory Submission and approval. - Risk Management for Medical Devices and Systems. - Cybersecurity for Medical Devices and Systems, including Consumer Product Cybersecurity. - Software Risk Management for Medical Devices and Systems. - Effective management, leadership, and mentorship of engineers. My research interests encompass Image Recognition, Digital Signal Processing, Computer Graphics, and Neural Networks (NN). I am a skilled communicator, both verbally and in written form, and I possess a natural aptitude for learning new skills. I am eager to expand my knowledge and willingly share my expertise with others.