Minneapolis, MN — May 22, 2013 — Diversified Plastics, Inc. has announced they are now registered for medical device production with the Center for Devices and Radiological Health (CDRH registration) at the U.S. Food and Drug Administration (FDA registration). Businesses involved in the production or distribution of medical devices are required to register annually with the FDA as part of a common path review procedure.
“This is a fairly new process for us as a contract manufacturer,” said Joe Bourgeault, Diversified Plastics quality director. “Contract manufacturers of finished devices now need to be CDRH registered as part of the product review process. Our registration with the FDA is required, because with many of our contract molding and assembly services, we are the last to touch the medical device before sterilization and use.
Annette Lund, vice president of Diversified Plastics adds, “We see this registration as an opportunity for us to continue growing in the medical device industry. It shows potential customers we have the capability to do the type of work that requires FDA approval.”
About Diversified Plastics, Inc.
Employee-owned Diversified Plastics is a custom injection molder of high-precision, close tolerance, small- to medium-sized injection molded components for medical device, filtration, aerospace and a variety of other industrial markets. The 36-year-old company is a full-service injection molder, from design assistance and mold construction, to intricate molding and clean room assembly. Diversified Plastics is ISO 9001:2008 and 13485:2003 certified, ITAR