
Bioject’s Portland, Oregon facility is registered by the U.S. Food and Drug Administration (FDA) as a medical device manufacturer. We are ISO 13485:2003 certified as well as EC certificates for our needle-free jet injection system, reconstitution kits and vial adapters.
Our cGMP manufacturing facility has an ISO 8 clean room with ISO 7 clean room capability and availability. Our flexible manufacturing lines allow us to react quickly to customers needs.
Our research and product development (R&D) department has a wide depth and breadth of needle-free experience and our efforts are focused on enhancing the company’s current product offerings and on developing new needle-free injection products to meet the needs of the partners and patients.
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