Sheila Ramerman, RAC, is the founder and Principal Consultant at SJR Associates, a medical device regulatory affairs/quality systems consulting firm with particular emphasis on near-patient testing technologies and in assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at several medical device companies in the San Francisco Bay Area. She has hands-on experience with a wide variety of medical devices, and has worked with a range of medical device companies, from start-ups to multi-national corporations. She has been Regulatory Affairs Certified (RAC) since 1998.