Paladin Medical offers a full range of medical product regulatory, clinical and technical contract services to the medical device industry. We have been providing our award-winning services to the medical device industry since 1987!
We guide our clients through the rapidly changing worldwide regulatory environment. Paladin Medical’s expertise and commitment to high performance have resulted in countless successful product submissions.
Extensive Product Experience
Paladin Medical has the hands-on engineering, development, and executive management experience that not all regulatory consultants can offer. We work with our clients to define the best regulatory approach for new products, helping companies small and large to develop premarket submissions, IDE trials and non-significant risk studies supporting the 510(k) process or PMA applications.
Our Experts are Industry Leaders
Paladin Medical includes a network of highly trained and experienced experts who offer clients valuable guidance and service. Continuing education is essential to maintaining quality service, and therefore we stay current on new regulations and regulatory practices. For more details, please read Paladin Medical’s Commitment to Continuing Education.
Elaine Duncan, M.S.M.E., RAC, is the President and founder of Paladin Medical and a recognized leader in regulatory and clinical strategies for new medical technology development. Prior to forming Paladin Medical in 1987, Elaine held key executive positions in start-up medical companies. She has had broad development experience in diverse areas, including artificial hearts, vascular grafts, and disposable sterile products, as well as unique clinical and pre-clinical testing experience.
In 1992, Elaine Duncan received the Medical Alley Outstanding Contribution to the Health Care Industry Award. Her service as the editor of Biomaterials Forum for over 12 years was recognized in 1999, with the C. William Hall Award from the Society for Biomaterials. In addition, Elaine has served on the board of directors and in other leadership positions of the Society for Biomaterials. She is a member of numerous biomedical organizations, including ASAIO, AAMI and BSME, as well as a frequent contributor to industry publications.
Elaine Duncan has served as advisor to biomedical engineering programs at the University of Minnesota (graduate with Masters in Mechanical Engineering/Biomedical) and serves on the Dean’s Advisory Committee at the University of Kentucky (graduate with Bachelor of Science Mechanical Engineering/Biomedical.) In April 2000, Elaine was honored with induction into the University of Kentucky College of Engineering Hall of Distinction, and in 2007, as a member of the Quadrangle Society. For more information, please read Elaine’s full bio.