Bright Plastics is ISO 13485:2003 certified for medical device manufacturing, as well as FDA-registered as a medical device manufacturing facility. Our ISO 8 (class 100,000) cleanroom features four all-electric molding machines. These qualifications, combined with our scientific injection molding process, position Bright Plastics to work with a diversity of medical and pharmaceutical companies.
Examples of medical device products in our portfolio:
Bright Plastics routinely performs IQ, OQ and PQ evaluations to comply with medical qualification protocol.
IQ – Installation qualification – We ensure that the equipment received matches the specifications we require and ordered, and that it is installed properly.
OQ – Operational qualification – We make sure the equipment runs the way it is supposed to run without material and prior to use in manufacturing.
PQ – Performance qualification – Finally, we test the machinery under load – in the case of a molding machine, this means with the amount of material it should hold, a mold in and running. We make sure that it effectively produces parts that fall within the intended capacity and function designed, and performs to medical qualification standards.
This three-step evaluation process applies to any type of machinery used in our medical manufacturing division.
Rely on Bright Plastics' design expertise, medical qualification process experience and lean manufacturing when you need a seasoned source for plastic injection molded components and assemblies. Call us at 336-668-3636, or email firstname.lastname@example.org.
"Bright Plastics has been our molding partner for over four years. We have been very happy to rely on them for high quality products and maintaining the integrity of our supply chain."
— Medical Device Components Supplier