Paladin Medical offers a full range of medical product regulatory, clinical and technical contract services for FDA and international premarket applications and regulatory compliance to the medical device industry.
Paladin Medical, Inc. and COVID-19
As in days of old, a paladin works in the service of others. Today we face the uncertainties of health and business in the face of a world-wide pandemic. Paladin Medical, Inc. continues to stand in service to medical device manufacturers around the globe. If you have questions about importing products which may help to fight the disease, such as test kits and protection equipment, please don’t hesitate to call or email at any time. If you need to contact regulatory officials with an urgent question, we will try to assist anyway possible. But rest assured, we are working diligently on all medical device applications and quality systems for all MEDICAL DEVICES. We consider our services ESSENTIAL.
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. 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, click here.
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 clinical studies supporting all aspects of premarket applications. Paladin Medical includes a network of highly trained and experienced experts who offer clients valuable guidance and service.
Elaine Duncan, MSME, RAC, FAIMBE 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 as well as senior development responsibilities at a major medical device manufacturer. From this broad development experience in diverse areas, including artificial hearts, vascular grafts, and disposable sterile products, Elaine brings practical, “real-world” knowledge of bringing complicated devices to market. A brief biographical sketch is provided here, and a full resume is available upon request. Elaine’s Full Bio.
LaVonne Waldon, Client Services Manager, joined Paladin Medical in 2016 to expand the client services. Ms. Waldon facilitates communication between the clients, the President and other consulting staff to ensure client requirements are met. She supports the company’s computer systems and the web-based document portal provided for client file interchange. Ms. Waldon brings over seven years’ experience with a blood perfusion monitor product as a customer service representative, conducting client training and sales support. LaVonne brings extensive database management skills as well as proficiency with Excel spreadsheet applications and validation to the services within the company. More information is provided. LaVonne’s Full Bio