Dr. Abraham's fields of expertise are focused on orthopaedics, orthobiologics, biomaterials, and translational research.
Dr. Abraham is an accredited Project Management Professional and has prior experience in managing large scale projects involving teams of people across multiple scientific and engineering disciplines. Dr. Abraham's project management experience includes leading multiple high performing, cross-functional, and interdisciplinary teams which impacted stakeholders within the pharmaceutical and medical device industries to deliver business, R&D, regulatory, and risk management strategies.
Dr. Abraham has supported medical device manufacturers in a variety of applications throughout the total product life cycle for Class I, II, and III medical devices. Her work includes, for example, assessment of quality management systems and manufacturing lines, postmarket surveillance support, and risk management. She is knowledgeable with respect to a number of important industry standards and regulations impacting the medical device industry including ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR 1271.
Dr. Abraham has supported qui tam and False Claims Act investigations involving medical device companies.