OEM Orthopedics assists medical device companies to dramatically lower the manufacturing costs of their orthopedic instruments and items associated with an orthopedic device. Surgical trays are a significant cost to any orthopedic medical device company and OEM Orthopedics will improve margins significantly by lowering the manufacturing costs of surgical tray components. By using our extensive network of orthopedic manufacturers, we can assist any orthopedic medical device manufacturer, in the production of high quality instrumentation and accessories for any primary orthopedic device. We offer full project management involving concept to design to final fabrication as well as working alongside your engineering, R&D groups manufacturing management to produce the highest quality instrumentation for your device. • Management of OEM projects on behalf medical device manufacturers.• Strategic Consulting, including business plan & sales strategy development.• Facilitation of joint venture, co-marketing and joint strategy initiatives between Medical device companies in the US and internationally. • Representation of US device companies in developing business in developing markets. OEM orthopedics also assists hospitals and surgical centers to source specific orthopedic medical instrumentation to support orthopedic surgical caseloads and decrease costs. Many international manufacturers wish to do business directly in the United States, and to contract directly with hospitals and surgical centers. OEM orthopedics is well-versed in all aspects of FDA credentialing. We help both manufacturers and hospitals and surgical centers to understand the complexities of the FDA process• Advising new business development on medical device development, FDA issues and regulation, FDA conformity, and corporate compliance to FDA regulations. • Development and implementation of validations necessary to facilitate purchase of devices by US medical entities. • Generated new development of medical devices, company compliance and, including medical device use and market analysis.