Dr. Muthu Dhandapani is a seasoned expert in quality, regulatory compliance, and clinical affairs for medical devices, diagnostics, and therapeutics. He holds a PhD in Cancer Biology and has authored five peer-reviewed publications. With 20 years of experience in the USA, EU, and India, he has worked on regulatory strategies for personalized cancer diagnostics, 3D bio-printed devices, IoMT, AI/ML algorithms, SaMD, POC, wearable devices, and predictive diagnostics. He has supported regulatory processes in 50+ countries and is involved in forums like TOPRA, RAPS, and CQI. Certified as an IRCACQI lead auditor for ISO 13485:2016 and MDSAP, and a Six Sigma, GMP, GCP, and GLP professional, he has contributed to multi-centric clinical studies and designed manufacturing units globally. Dr. Dhandapani has worked with ministries such as CDSCO, ICMR, and the Ministry of Commerce on quality and regulatory approvals. He mentors start-ups in various incubators and is a member of the BIS technical expert committee. He has received the Indian Achievers Award (2018) and Bharat Vikas Award (2019).