Accenture
Ajit Mallik is the EU MedTech Clinical Lead within Accenture, with 15+ years of global RA/QA experience across all classes of Medical Devices, and IVDs, with a focus on SaMD and Digital Health products. He also focuses on clinical evidence generation towards the regulatory strategy, throughout the product life cycle.
He has also successfully delivered cross-functional roles across Medical Affairs, Clinical Affairs and Business strategy for the market entry, clinical trials and liaising with regulatory authorities for all classes of Medical Devices and Digital Health platforms.
He is a Subject Matter expert in Orthopedics, Neurology, Cardiology, Obstetrics & Gynecology, Diagnostics and Applied clinical medicines.
He studied Medicine in India and earned his MD PhD from University of Zurich, Switzerland. He has a Masters in Medical Science and Technology, from IIT Kharagpur, India.
He was also a visiting scientist at Harvard Medical School, Boston, USA.
Accelerating Regulatory Discussion on Digital Health Devices
Thursday, October 9, 2025
3:15 PM - 4:15 PM EST