Medical Device Quality and Design

KIRAN GULATI is an instructor and 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. Gulati has a proven track record assisting medical device companies with preparing for MDSAP, ISO 13485, EU MDR, and QMS audits with regulatory agencies. She has worked at Genentech and McGhan Medical (formerly Collagen Corp.), 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, and the ASQ Silicon Valley Division. At UCSC Silicon Valley she teaches Quality Systems for Medical Devices: ISO 13485 and FDA Requirements and Conducting Value-Added Audits. Gulati enjoys volunteering with the local RAPS chapter and was chair of the San Francisco Bay Area RAPS Chapter (2011-2014).  In 2013 and 2014, she planned meetings and collaborated with representatives from the Center for Devices and Radiological Health to help educate industry on the Case for Quality Initiative. As a volunteer for RAPS, she 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." Gulati enjoys teaching and mentoring her students and professionals who are aspiring to work in the medical device/biotech industries. In August of 2020, Kiran was awarded the RAPS Community Leadership Award for her contributions to the regulatory profession.