Gulati

Kiran is the Program Chair of the Regulatory Affairs and Medical Device Quality & Design Certificate programs at UCSC Silicon Valley Extension.  She is also the Principal Medical Device Consultant at Kiran Gulati & Associates with over 30 years of experience working with medical devices.  She is an Exemplar-certified lead auditor and provides companies with guidance with global regulatory compliance strategies.   Kiran has a proven track record with assisting medical device companies with preparing for MDSAP, ISO 13485, EU MDR and QMS audits with regulatory agencies.
 

She worked at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the corporate audit functions and led quality management system integration efforts.

 

She has extensive experience in designing corporate training 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.   She is an instructor at UCSC Silicon Valley where she teaches:  Quality Systems for Medical Devices: ISO 13485 and FDA Requirements and Conducting Value-Added Audits. 

 

Kiran enjoys volunteering with the local RAPS chapter and was Chair of the San Francisco/Bay Area RAPS Chapter from 2011-2014.  In 2013 and 2014, Kiran planned meetings and collaborated with representatives from CDRH to help educate industry on the Case for Quality Initiative.  As a volunteer for RAPS, Kiran has also served on the Convergence Planning Committee, on the Nominating Committee for the RAPS Board of Directors and recently served as a Section Reviewer for RAP’s new publication:  Fundamentals of Medical Device Regulations: A Global Perspective.

 

Kiran enjoys teaching and mentoring her students and professionals who are aspiring to work in the medical device/biotech industries.

 

In August, 2020, Kiran was awarded RAPS Community Leadership Award for her contributions to the regulatory profession.