Regulatory/Quality
Bioject Medical Technologies Inc.’s Portland, Oregon facility is registered by the U.S. Food and Drug Administration (FDA) as a medical device manufacturer. The Company has an excellent record of quality systems compliance with FDA, as well as compliance with international quality systems standards.
Bioject's Quality Policy
Bioject maintains a quality management system that fulfills applicable regulatory requirements and assures the design, manufacture and delivery of safe and effective products that meet our customers' needs.
All Bioject products are manufactured to uncompromising design, process, inspection and testing standards.
Bioject's ISO Auditor, Underwriters Laboratories, Inc., has certified Bioject to the following International Standards.
In cooperation with our Notified Body, Underwriters Laboratories, Inc., Bioject maintains the following product certifications:
EC Certificate for Needle Free Jet Injection System
EC Certificate for Sterile Reconstitution Kits and Vial Adapters