Dinesh is a preeminent U.S. Regulatory Advisor in the Medical Device industries, with a specialized focus on Digital Health & Imaging, Wearables, AI & ML devices, and Software as a Medical Device (SaMD). His expertise extends to a profound understanding of FDA laws and regulations, where he excels in offering unparalleled value and risk mitigation. Dinesh’s capabilities are not just limited to advisory roles; he is also highly skilled in implementing varied strategies for all FDA submissions, ensuring comprehensive and proficient management of regulatory processes.
Recognized globally, Dinesh is part of an elite group known for their talent and experience in the medical device and biologics sector. His achievements are marked by an exceptional track record in Pre-Market Approval (PMA) submissions, especially notable in the rapidly evolving fields of Wearables, AI & ML devices, and SaMD. With his extensive knowledge and leadership, Dinesh provides exemplary guidance and representation in all facets of US FDA regulatory affairs, adeptly navigating the intricate landscape from device conception to commercialization. He is particularly adept at demonstrating the scientific, safety, and efficacy credentials of a diverse range of technologies in these advanced and specialized areas.