“Theorem works with Ximedica to create design solutions that meet the safety and use requirements of a wide range of populations, thereby minimizing risk during the regulatory review process”
With deep expertise in human factors engineering, industrial design, mechanical, electrical and software engineering, advanced manufacturing services and regulatory requirements, Ximedica brings more than 25 years of experience developing medical devices, combination products and consumer health care products to the alliance.
Ximedica’s product development experience includes programs involving complex electro-mechanical systems, fluid management systems, graphical user interfaces, portable or wearable systems and systems with cutting-edge wireless technology and miniaturization solutions.
“Theorem works with Ximedica to create design solutions that meet the safety and use requirements of a wide range of populations, thereby minimizing risk during the regulatory review process,” said D. Lee Spurgin Jr., Ph.D., Theorem senior vice president and general manager of medical device and diagnostic development. “We feel these types of business alliances allow us to offer a better end product to clients.”
“Recognizing that a growing number of our product development programs are requiring large-scale, multi-center global clinical studies, it made sense for Ximedica to partner with a reputable, global CRO such as Theorem. Our combined expertise provides a more compelling solution for our global clients,” said Ximedica CEO Randall S. Barko.
About Theorem Clinical Research
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM.
Ximedica is a full service ISO 13485 certified and FDA registered product development firm with an exclusive focus on medical products. With more than 25 years of experience developing medical devices, combination products and consumer healthcare products, Ximedica’s client base spans the globe and ranges from start-ups to the world's largest OEMs. www.ximedica.com.