Plamena Entcheva-Dimitrov is a regulatory, clinical and quality management consultant, specializing in the areas of combination products, drug delivery catheters, implantable devices and imbedded and standalone software. Her efforts have allowed patient access to novel technologies and have brought innovative products to the market, expanding and solidifying clients' portfolios in the areas of cardiovascular, pulmonology, urology, women's health, nephrology, ENT, ophthalmology, orthopedics, neurology, and metabolic diseases. Plamena’s repertoire includes investigational and marketing submissions for devices and drugs world-wide. Because of her strong scientific background, Plamena is involved in managing projects from early stage to commercializations. She has experience in conducting internal and supplier audits, handling FDA/FDB and notified body audits. She has written numerous procedures, handled document control, and assessed and revamped quality systems in medical device and pharmaceutical companies. Her knowledge of design controls and risk management helps her guide companies on the most compliant path to develop medical devices.

Plamena teaches regulatory affairs, and medical device innovation classes at Stanford and UCSC Extension and serves as an instructor for the San Francisco RAPS chapter and third party on-line training providers. Since 2008, Plamena holds RAC certificate and since 2013, she is a voting member of AAMI. Plamena is a sought out speaker at various industry events, where she brings her US and international experience in medical product development. Plamena is also the founder of an Eastern Europe oriented US-based CRO focused on accelerating medical innovation and commercialization of medical products to the global markets by reducing clinical study time and cost. Prior to joining the regulated industry, Plamena was a postdoctoral fellow at Stanford. She holds a PhD in microbiology and genetics, MS in microbiology and in environmental biotechnology.

Our Team

Our team consists of seasoned consultants with extensive experience in the areas of regulatory affairs, clinical research and quality management who are deployed on a project basis to quickly and efficiently achieve the end goal.