About Paladin Medical®
Paladin Medical®, Inc. offers a full range of medical device regulatory, clinical, and technical services for FDA and international premarket applications. We provide bedrock training and procedure templates to assure regulatory compliance as the product is developed and your company evolves.
Unparalleled Experience
Paladin Medical’s® expertise and commitment to high performance have resulted in countless successful product submissions.
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Paladin Medical® has the direct engineering, development, and executive management experience that most regulatory consultants cannot offer. We collaborate with our clients to define the best regulatory approach for new products, helping companies small and large to develop premarket submissions, requirements documentation, risk analysis, preclinical and clinical studies supporting all aspects of premarket applications or approval.
Leadership
Elaine Duncan, MS.ME., RAC, FAIMBE, FBSE is the President and Founder of Paladin Medical®. She is a recognized leader in regulatory and clinical strategies for new medical device technology. She is an Adjunct Professor of Biomedical Engineering at the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, College of Engineering, Stan and Karen Pigman College of Engineering, University of Kentucky. Prior to forming Paladin Medical® in 1987, Elaine held key executive positions in start-up medical companies as well as senior development responsibilities and acquisition assessment responsibilities at a major medical device manufacturer. From this broad experience in diverse medical areas, including artificial hearts, vascular grafts, and neurological implants, Elaine brings practical, “real-world” knowledge of taking your product to market. Ms. Duncan has been named FELLOW to the American Institute for Medical and Biological Engineering and FELLOW by the International Union of Societies for Biomaterials Science and Engineering.
Click here for Ms. Duncan’s Full CV.
LaVonne Waldon, Client Services Manager, joined Paladin Medical® in 2016 to expand client services and support. Ms. Waldon facilitates communication between the clients, the President and other consulting staff to ensure client project requirements are met. She manages the company’s computer systems and the web-based document portal provided for client file interchange and supervises the compliance of company quality system templates.
Ms. Waldon brings over seven years’ experience with a blood perfusion monitor product as a customer service representative, conducting client training and sales support. She has extensive database management skills, a relaxed communication and management style overseeing and supporting all aspects of company operations and services. LaVonne is our resident “Librarian” who keeps company details in order.
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A Brief History of Paladin
The modern meaning of the word “Paladin” is a heroic champion and strong supporter or defender of a cause. It is derived from the Latin “palatines,” meaning “of the palace,” and came to mean a warrior or knight. The twelve knights of Charlemagne were called Paladins; their mission to solve disputes between the king’s subjects. Numerous video games now try to capture the heroism.Without doubt the most indelible PALADIN from late 1950s was played by Richard Boone in the popular Western “Have Gun Will Travel”. He solved problems with intellect, not gunfire. The knight symbol on his business card conveyed his message of stoic service.
For more details about our many services and customized training, please contact us. Please connect with us on LinkedIn