Team

With over 7 years of experience in clinical research, Ami specializes in clinical evaluation and pre- and post-market clinical strategy for medical devices, navigating complex global regulatory landscapes, including EU MDR and FDA. She has led the successful transition of multiple legacy devices into the EU MDR framework and driven pivotal market approvals for novel devices across the EU, US, and Australia. With a keen eye for critically interpreting and analyzing clinical data, Ami is adept at conducting a holistic clinical evaluation and risk-benefit analysis, with due consideration of alternative therapies and rigorous, state-of-the-art analysis. Her work has spanned multiple therapeutic domains, including cardiovascular and neuromodulation, and has involved significant cross-functional collaboration with regulatory affairs, risk management, and research and development. She has led the design, execution, and analysis of pre- and post-market clinical studies and strategies, directly engaged with regulatory bodies including BSI, FDA, and the Swedish MPA, and mentored team members throughout her career. At Aprnaik Consulting, Ami is committed to leveraging her expertise to drive innovation in the medical device space and advance solutions that impact patient lives.​