Abhinavdutt Singh

Abhinavdutt Singh is a Quality Engineering professional with more than 10 years of experience in medical device manufacturing, specializing in Class II and III electromechanical devices, including neuromodulation, CGM systems, robotic platforms, ophthalmic systems, and Software as a Medical Device (SaMD). In his current role as a Staff Quality Engineer at iRhythm Technologies, he leads software validation and quality engineering efforts for digital health technologies across both new product introduction and sustaining engineering. His expertise includes driving SDLC best practices, implementing risk management and compliance strategies across FDA, ISO, IEC, cybersecurity, privacy, and emerging AI governance standards, and validating manufacturing automation, AI/ML, and SaMD solutions. Previously, he served as a Senior Software Quality Engineer at Auris Health (Johnson & Johnson), overseeing design controls, risk management, and IEC 62304 compliance for robotic surgical systems while strengthening cross-functional collaboration. He is passionate about bridging innovation and compliance to ensure advanced technologies improve patient outcomes while meeting rigorous quality and regulatory expectations.