Abhinav Singh

Abhinav Singh is an experienced Software Quality Engineer with over nine years in medical device manufacturing, specializing in Software as a Medical Device (SaMD), regulatory compliance, and AI/ML integration. Currently at iRhythm Technologies, he leads validation and risk management strategies to ensure adherence to FDA 21 CFR 820, ISO 13485, and EU MDR standards. Abhinav's expertise spans new product introduction, cybersecurity, and process automation. He has presented at international conferences and has contributed significantly to innovations in digital health solutions and advanced quality frameworks.