Optinova is delighted to announce that its Valley Forge facility in Pennsylvania, USA, is now officially certified to ISO 13485 standards. This milestone marks a major advancement in our commitment to delivering high-quality, medical-grade tubing solutions to meet the growing needs of the U.S. healthcare market.
Previously focused on high-performance tubing for demanding industrial applications, Optinova Valley Forge has now expanded into the medical sector. The facility also recently unveiled a newly constructed, state-of-the-art Class 8 Cleanroom during an inauguration and ribbon-cutting ceremony with the Optinova Board of Directors in May 2025. “The Optinova team and I are excited to serve US customers with high-quality medical extrusion solutions,” said Plant Manager Vincent Torelli.
The new cleanroom is already supporting several production lines, with the first medical-grade product runs expected to be completed by June of 2025.
These developments represent a key milestone in Optinova’s global growth strategy. “Our investments in cleanroom technology and ISO certification at Valley Forge strengthen our ability to support U.S. customers with local, high-quality production capabilities. We’re proud to deliver solutions that help improve lives, right here in the heart of Pennsylvania,” says Optinova’s CEO Rom Mendel.
Through strategic investments in innovative technologies and infrastructure, Optinova continues to reinforce its role as a global leader in medical extrusion solutions. With the addition of the cleanroom and ISO certification at Valley Forge, Optinova offers its customers cleanroom medical extrusion solutions on three continents (USA, Europe and Asia).
For questions, please contact:
Michael Levitt, VP Sales Operations & Marketing
Email: michael.levitt@optinova.com
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