The certification is said to signify the company’s adherence to stringent protocols in the development and production of regulated medical products.
BROCTON, N.Y.—Jamestown Plastics reported that it received ISO 13485:2016 certification, underscoring the company’s commitment to operating a robust quality management system within the medical device sector. The ISO 13485 certification signifies Jamestown Plastics’ adherence to stringent protocols in the development and production of regulated medical products, the company said in a release.
A trusted supplier to North American medical device companies, Jamestown Plastics specializes in crafting tailored medical device packaging for use in healthcare facilities worldwide. The company recently launched Jamestown Plastics Medical and joined the MedTech Network, a global consortium of independent firms dedicated to delivering top-tier products and services to the medical sector.
Jamestown’s new certification covers “design and management of manufacturing custom thermoformed packaging,” according to the company’s accreditation certificate, and is said to reaffirm the company’s commitment to advancing healthcare standards.
“As we continue to expand and innovate across different sectors, our primary focus remains on delivering competitive excellence,” said Jamestown Plastics CEO Jay Baker, in a statement. “With our initial ISO 9001 certification dating back to 2004, we recognize the significance of obtaining ISO 13485 within the medical industry, where we have demonstrated expertise.”
According to the company, its ISO 13485 certification, coupled with its state-of-the-art ISO Class 7 cleanroom facilities, empower Jamestown Plastics to provide customers with superior medical device packaging.
“Achieving ISO 13485 certification distinguishes Jamestown Plastics as one of the few U.S.-based custom plastics thermoformers with this esteemed accreditation,” said Jamestown Plastics President Jessup Baker, in the release. “This milestone solidifies our position as a premier supplier to the medical device industry.”