Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic devices, and covering products of all risk classifications. Sreenu’s background includes establishing regulatory strategies for registrations; integration activities; compiling EU technical files; CSDTs for APAC submissions; US FDA 510ks; TGA submissions including Clinical Evaluation Reports and Post Market Surveillance. He also has experience in ISO 13485 audits, gap assessments and US FDA QSIT Inspections. In his current role, Sreenu manages the regulatory and quality compliance needs of EMERGO’s APAC and international clients. Prior to joining EMERGO by UL, Sreenu held regional and leadership positions at Life Technologies (now part of Thermo Fisher Scientific), Vela Diagnostics, Cardinal Health and Abbott.
Sreenu Sattu - India
Manager Quality Assurance and Regulatory Affairs
Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic devices, and covering products of all risk classifications.
