OBI

OsteoBiologics, Inc. (OBI), located in San Antonio, Texas, develops and manufactures bioabsorbable scaffolds for the repair and replacement of bone and cartilage. OBI employs highly qualified professionals in the areas of biomechanics, biomaterials and biologics. In-house capabilities are fully integrated and range from research and development through final manufacture and packaging of products. OBI is housed in an 11,000 square foot facility that includes cleanrooms, research and development laboratories, machining services for rapid prototype development, as well as quality control and histology laboratories. Machining Services supports all departments through its ability to rapidly prototype and manufacture novel tooling and equipment, as well as manufacture custom parts for customers. As part of its commitment to developing and manufacturing quality medical devices, OBI has been ISO certified since 1999. ISO 13485 certification is a model for quality assurance in design, development, and production, specific to medical devices. By maintaining a quality system that meets ISO, FDA, CMDCAS and 93/42/EEC requirements for medical devices, OBI has built upon the company's core objective of total quality management to meet both national and international standards. These certifications are also essential to OBI's strategy for gaining international product approval, such as the CE Mark for European distribution, since having ISO 13485 certification greatly eases and accelerates the approval process.