Sheila Ramerman is an independent consultant who has 30 years of experience in the medical device industry, including consulting medical device companies since 2003. Sheila is especially familiar with In Vitro Diagnostic Devices and other point-of-care testing devices. She has extensive expertise with Software as a Medical Device (SaMD), body-worn sensors, and medical apps. She primarily works with entrepreneurs, start-ups, and small companies.
Products Sheila has worked with range from complex, software-controlled devices for detection, diagnosis, and therapy to hospital, neurology, physical medicine, and surgical devices. In the past, Sheila has been a webcast instructor for BioPractice.com and was active in the early days of OBA’s WorkForce Training program. In the US, she has successfully submitted numerous pre- IDE/pre-submissions, over 40 Traditional and Special 510(k) submissions, a radiology image analysis software PMA, and multiple DeNovo applications. Worldwide, Sheila has experience with premarket and postmarket requirements in Canada, the EU, and the Asian-Pacific regions.
Sheila has an AA degree in Clinical Laboratory Technology from Shoreline Community College and a BA in Health Services Administration from Saint Mary’s College. She has been Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society since 1998, and RAC-Devices certified since 2019.