 |
We conduct our manufacturing operations at our facilities in Carlsbad, California. We manufacture substantially all of our implants in our Carlsbad facilities. We believe that the in-house production of our implants maximizes efficiency, reduces product development time, simplifies production scheduling, reduces inventory backlogs and is more responsive to the changing needs of surgeons. Our facilities include distinct areas dedicated to the machinery, tooling, quality control, cleaning, labeling and distribution of our products. Additionally, we have a stand-alone Product Specialty group that includes design engineering and manufacturing personnel. The Product Specialty group is dedicated to providing rapid prototyping and innovative custom instrumentation for the surgeon community.
We devote significant time and attention to ensure that all of our products are safe, effective, adhere to all applicable regulations and are of the highest quality. An established and comprehensive quality system drives our focus from the initial translation of surgeon needs into design specifications through an exhaustive series of quality control checks that are performed during the design, purchasing, manufacture, production, packaging and distribution of our products. We record the complete production history for every product, ensuring full design traceability from the design stage through the delivery of the product into the marketplace.
|
|
