Abhinav Singh

Abhinav Singh is a seasoned Software Quality & Systems Engineering Leader with over 9 years of experience in safety-critical domains, including medical devices, SaMD, and AI/ML-based digital health solutions. As a Staff Software Quality Engineer at iRhythm Technologies, he specializes in ensuring regulatory compliance (21 CFR 820, ISO 13485, IEC 62304) and leading software validation efforts for high-impact products across global markets. He is an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and has successfully led cross-functional teams through design controls, risk management, process validation, and post-market surveillance. His areas of expertise include FDA 510(k) submissions, cybersecurity risk assessments, and manufacturing process optimization, with initiatives saving over $1.5M annually through digital transformation. In addition to his industry work, Abhinav is an active contributor to several global AI governance initiatives. He is involved with the IEEE SA IC Program, ForHumanity, and OWASP (AIMA & CTI Projects)—advocating for the development of ethical, secure, and compliant AI frameworks in healthcare. He has authored and reviewed technical publications and frequently speaks and judges at leading conferences such as WhySummit, TT Life Science, ASQ Sessions, and IEEE events.