KIRAN GULATI, Exemplar Medical Device Lead Auditor (Cert No. 6111), M.B.A. is a management consultant with more than 29 years of experience in the area of quality systems and process improvement in the medical device and biotech sectors. She has held positions at Genentech and McGhan Medical (formerly Collagen Corp.) where she managed the auditing and quality system training functions. She has extensive experience in designing, developing and presenting training for companies in both domestic and international settings. Since 2001, she has assisted a large number of startup and large medical device companies to achieve successful results for MDSAP, ISO 13485:2016, CE Mark assessments, and FDA audits.
Gulati has served as a RAPS board member for the past 15 years, including several years as chair of the San Francisco Bay Area chapter of the Regulatory Affairs Professionals Society (RAPS). She worked with representatives from Center for Devices and Radiological Health (CDRH) on the Case for Quality sessions and served on the RAPS North American Advisory Board. She is currently on the Nominating Committee for the RAPS Board of Directors and has been a speaker at conferences such as the RAPS Regulatory Convergence, the Institute of Validation Technology (IVT), and the ASQ Silicon Valley Division. Gulati serves as chair of both the UCSC Extension Regulatory Affairs and Medical Device certificate programs.