Shreya Datta, PhD, located in Portland (Oregon) is the owner and principal consultant of SD Bioscience Services LLC. She received her Ph.D. in Chemistry from Purdue University (West Lafayette, Indiana) and has spent the last decade in the medical device sector (iota Biosciences, Nuvasive (now Globus Medical) and Acumed) focusing on biological evaluation of medical devices, cleaning and sterilization validations with adequate understanding of quality management system, risk assessments, design control and regulations of medical devices. During these tenures, she has contributed to many 510(k), IDE and EU-MDR submissions of medical devices (Class I-III) including combination devices. Currently, she is also a committee member of the ISO/TC 150/WG 16 “Antimicrobial properties of implants”.

With over 20 years of combined experience across academia and the medical device sector, she is staged to help companies to confidently navigate the preclinical landscape. Her mission is to demystify the processes, minimize risk, and help manufacturers deliver safe, compliant products that meet real clinical needs.