Dr. Ajit Sankar Mallik leads the EU MedTech Clinical Practice at Accenture. With 15+ years of global clinical, regulatory, and quality affairs experience, he specialises in Medical Devices, Drug-Device Combinations (DDC), and In Vitro Diagnostics (IVDs), with a strong focus on Software as a Medical Device (SaMD) and Digital Health products.
His expertise spans clinical evidence generation, regulatory strategy development, and product lifecycle management, ensuring compliance with FDA, EMA, Health Canada, Swissmedic, and EU Notified Bodies. He has played a key role in achieving Notified Body Opinions (NBOp) under Article 117 of MDR for various DDCs, including insulin and GLP-1 therapies.
Dr. Mallik holds an MDPhD from the University of Zurich, a Master’s degree in Medical Science & Technology from IIT Kharagpur, and was a visiting scientist at Harvard Medical School. His regulatory leadership has contributed to breakthrough device designations, per-market approvals, and Medical Device Regulation (MDR) compliance across global markets. His work integrates AI-driven automation and regulatory intelligence, optimising safety reporting and market entry strategies for DDC products.
