Roanoke-based Plastics One has achieved Quality Management System ISO 13485 certification for medical device manufacturers. They have also been re-certified for ISO 9001.
Here is a press release from Plastics One.
In a continued effort to bring quality support and products to their customers, Plastics One is pleased to announce the achievement of Quality Management System ISO 13485 certification for medical device manufacturers as well as the recertification of the ISO 9001. President and Chief Executive Officer of Plastics One, David Wallenborn, states that “ISO 13485 certification is a proud accomplishment for all of us at Plastics One and reflects our deeply held commitment to excellence in manufacturing and service to our customers worldwide.”
Plastics One is a contract manufacturer specializing in injection and insert molded components for the medical device industry.
Located in Roanoke, VA the ESOP Company currently employs 325 exceptional employee owners. The facility encompasses 85,000 square feet and boasts an in-house design department that utilizes three-dimensional software, a fully equipped mold making shop, prototyping, ISO 7 & 8 cleanrooms and the latest injection molding technology.
The company has been partnering directly with OEMs and Neuroscience researchers worldwide since 1949 by working together to provide solutions to industry needs. The company specializes in the design, molding, and assembly of components and electronics for the medical device industry. Each product is designed with tight tolerances to fit even the smallest device including parts that are assembled under a microscope. Plastics One also manufactures and assembles innovative devices for patient diagnostics and monitoring, nerve integrity monitoring, hearing enhancement, audio and communications, as well as sleep and respiratory studies. Their specialty is the design and build of custom cable assemblies with unique and complicated design requirements.