Shruti Gangwal has been covering the position of Regulatory Lead for BSI Notified Body for the past 3.5 years, where she is responsible for ensuring the organisation’s ongoing regulatory compliance and overseeing its overall regulatory framework. Prior to joining BSI, she gained approximately 12 years of experience in the medical device industry, specialising in regulatory affairs and quality management.

Ester Leoni is Global Regulatory Communication Manager for Medical Devices and IVDs at BSI. Prior to her role at BSI, Ester worked in the Swiss orthopaedic manufacturing sector specialising in Sports Medicine Marketing, and in the Public Hospital System, contributing to Quality Management and Communication. Ester joined BSI in 2022 bringing cross-functional expertise to support manufacturers navigating the evolving regulatory landscape in the medical technology space through marketing and communication.