Dr Dhandapani is a seasoned quality, regulatory compliance and clinical professional for medical device & diagnostics. He holds PhD in Cancer Biology; authored 5 peer reviewed international publications with the google scholar citation index of 434. He has worked on regulatory strategy for personalized cancer diagnostics, 3D Bio-printed devices, IoMT (Internet of Medical Technology), Point of Care (POC), wearable devices, artificial intelligence and machine learning algorithms, Software as a Medical Device (SaMD), prognostic and predictive diagnostics and has over 19 years of work experience gained from USA, EU and India. He has long experience in the official registration process of 50+ countries. He is actively engaged in various medical device industry forums such as TOPRA, RAPS, CQI and MDG Boston. He is an IRCA-CQI certified lead auditor for ISO 13485:2016, MDSAP and certified Six Sigma, GMP, GCP and GLP professional. He was part of few multi-centric clinical studies in EU, USA and India. He designed and established 5 manufacturing units in US, EU and India.
He has worked with various ministries like Ministry of Health (CDSCO, ICMR, IPC, PCPNDT), Department of Science and Technology (DSIR), Director General of Foreign Trade, Ministry of Chemicals & Fertilisers (Department of Pharmaceuticals, NPPA), Ministry of Environment and Forest (NOC, CPCB-EPR), Ministry of Commerce, Ministry of Communication and Information Technology (Department of Telecommunication, Department of Electronics and IT) , Atomic Energy Regulatory Board (eLORA), Ministry of Consumer Affairs and Public Distribution (Legal Metrology, Government e-Marketplace) and Quality Council of India for various quality and regulatory matters and approvals.
He has mentored 30+ MedTech Start-ups in India which are part of Indian School of Business (ISB), StartupTN (Government of Tamil Nadu), Yenepoya Technology Incubator, DERBI (Dayananda Sagar Entrepreneurship Research & Business Incubation Foundation) , C-CAMP (Centre for Cellular & Molecular Platforms), BBC (Bangalore Bioinnovation Centre) and SIPCOT Siruseri IT Park. He is also part of technical expert sectional committee of Bureau of Indian Standards (BIS) to develop standards for diagnostics and health informatics. He is a recipient of Indian Achievers Award (2018) & Bharat Vikas Award (2019).