All Four Optinova Plants Now Certified for Medical Tubing Production
Optinova is proud to announce that its Jomala extrusion facility has officially earned ISO 13485 certification, a globally recognized standard for quality management systems in the medical device industry.
With this certification, the Jomala facility joins Optinova’s three other production sites in delivering high-performance medical tubing solutions. This milestone solidifies Optinova’s position as a global leader in medical extrusion, with all four facilities now fully equipped to serve the healthcare market.
“Expanding medical extrusion capabilities to our Jomala facility represents a strategic step in supporting the growing demands of the healthcare industry,” said CEO Rom Mendel.
ISO 13485 certification ensures adherence to stringent regulatory requirements throughout the product lifecycle—from design and development to production and delivery. It underscores Optinova’s dedication to excellence, reliability, and continuous improvement. “This achievement enhances our ability to deliver consistent, high-quality tubing solutions to our customers worldwide,” said Jonas Lindström, COO. “It reinforces our role as a trusted partner in advancing medical technologies.”
The certification of the Jomala facility is part of Optinova’s broader strategy to supply high-performance medical tubing across a wide range of critical application areas.
These include advanced materials such as PEEK, PTFE, and FEP, designed to meet the needs of cardiovascular, vascular, endoscopy and urology applications.
Through ongoing investment in infrastructure and innovation, Optinova continues to lead the way in extrusion technology for medical applications.
For questions, please contact:
Michael Levitt, VP Sales Operations & Marketing
Email: michael.levitt@optinova.com
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