Intravenous medical devices are one of the most technically challenging product lines to produce. Most IV device parts are very small and have extremely tight specifications and tolerances. BMP Medical utilizes it’s expertise in statistical process control, automation, decoupled molding processes, and quality control procedures to manufacture these components. With tolerances that are often times +/- 0.0005”, precision manufacture and QC techniques are utilized to ensure the product meets specification and does not pose any safety concerns to the customer. Validation (IQ, OQ, PQ) is imperative at the beginning to establish that tight process window required to produce these parts. We work closely with our OEM customers to provide the documentation and protocols necessary for this validation process.