Medical device quality is dependent on factors such as mold design, processing, polymer resin selection and outsourced components. Lot-to-lot variability can affect the performance of the final product. Pacific Plastics & Engineering offers a lot history record validation and verification program. While we aggressively seek new materials to suggest improvement of quality and cost reductions for our clients, we also note when or if material changes occur.
Our medical grade metals also come from qualified vendors in fully traceable batches and lots. The PPE quality assurance team trains for continuous process improvement and possesses some of the most sophisticated and accurate measuring and inspection equipment available. Our metals are biocompatible, implant grade alloys that the medical device industry requires.
If measurements and temperatures need to be taken, we use certain gauges that meet national standards of quantification. Every aspect of your device is carefully inspected before we give our approval for packaging.
