Stratasys Ltd. announced on February 4, 2025, that its Stratasys Direct manufacturing facility in Tuscon, Arizona, has achieved ISO 13485 certification. This globally recognized standard is crucial for quality management systems in medical device manufacturing.
The certification formally recognizes Stratasys Direct for the safety, precision, and reliability of its 3D-printed components, addressing critical regulatory requirements. This achievement removes barriers to adoption, enabling medical device manufacturers to scale production reliably.
Stratasys plans to extend this certification to its other Stratasys Direct manufacturing facilities in Texas and Minnesota. This expansion of certified capabilities positions 3D printing as an essential tool for the medical device industry, accelerating innovation, reducing costs, and improving patient outcomes.
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