Presenter

Piyush is a seasoned HF leader with extensive experience across various companies, specializing in Human Factors Engineering (HF) for medical devices from Class I to Class III. Notably, he led HF efforts at Intuitive Surgical for the da Vinci robotic system, pioneered HF work at Amgen, and established HF groups at Alcon and Takeda. With hands-on expertise and leadership, Piyush tailors HF strategies to clients' needs, considering regulatory requirements, project timelines, and resource constraints. He maintains a network of ex-FDA HF reviewers and engages with reviewers based on the relevance of their past FDA experience. Piyush has been a contributor to the development of the International Usability Standard IEC 62366 and various FDA HF guidance. He has vast experience in guiding clients through successful FDA, MDR, and global HF submissions.