Medical Device Auditing, Training & Consulting
WHO I AM
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 Corporation) where she managed the auditing and quality system training functions. Ms. Gulati 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 medical device companies (both start-up and large) in achieving successful results during MDSAP, ISO 13485:2016, CE Mark assessments and FDA audits.
Kiran is the Program Chair of UCSC’s Regulatory Affairs and Medical Device Certificate Programs and serves on the UCSC Advisory Board. As an instructor, she currently teaches: Medical Device Quality Systems (ISO 13485:2016/FDA Medical Device Quality System Regulation) and Conducting Value-Added Audits. In addition, Kiran has been a speaker at conferences such as the RAPS Regulatory Convergence, the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division
Kiran has served as a RAPS Board member for the past 15 years and served as the Chair of the San Francisco/Bay Area RAPS Chapter from 2011-2014. In 2013 and 2014, Kiran worked with representatives from CDRH on the Case for Quality sessions. She served on the RAPS North American Advisory Board and is currently on the Nominating Committee for the RAPS Board of Directors.